Intelligence · Clinical Pipeline

Phase I Pipeline Programs

First-in-human and early clinical safety studies in Phase I.

Programs
4,713

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NovaPharmaNews tracks 4,713 phase i pharmaceutical pipeline programs from ClinicalTrials.gov. First-in-human and early clinical safety studies in Phase I.

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  1. An Ophthalmic Safety Study of New Investigational Drug in Breast Cancer Patients

    AstraZeneca AB

    Breast Cancer

    phase 1 other active

    1 trial
  2. An adaptive, randomized, double-blind, single-center, placebo-controlled first-in-human study evaluating safety, tolerability and exposure of single and multiple ascending doses of Lactobacillus expressing CXCL12 administered topically to experimentally induced skin wounds

    Lacuna Pharma Pty Ltd

    Wound healing

    phase 1 other active

    1 trial
  3. An early Phase 1b Study to assess how safe and effective is the treatment with drugs, called Mosunetuzumab or Glofitamab in Combination with drugs called, CC-220 and CC-99282 in Patients with B-Cell Non-Hodgkin Lymphoma.

    Hoffmann-La Roche

    Non-Hodgkin Lymphoma

    phase 1 other active

    1 trial
  4. An exploratory study to investigate the effect of FE 999302 when given during different time periods to women undergoing controlled ovarian stimulation with follitropin delta

    Ferring Pharmaceuticals

    Infertility in women undergoing assisted reproductive technologies (ART)

    phase 1 other active

    1 trial
  5. An exploratory study to investigate the effect of FE 999302 when given together with follitropin delta during controlled ovarian stimulation

    Ferring Pharmaceuticals

    Infertility in women undergoing assisted reproductive technologies (ART)

    phase 1 other active

    1 trial
  6. An exploratory study to investigate the impact on the viral reservoir of adding a broadly neutralizing antibody with or without an attachment inhibitor to an integrase inhibitor-based antiretroviral therapy regimen in adults living with HIV (ENTRANCE)

    ViiV Healthcare Pty Ltd

    HIV Infections

    phase 1 other active

    1 trial
  7. An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Empagliflozin Tablets 25 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Jardiance (Empagliflozin) 25 mg film-coated tablets, Marketing Authorisation Holder Boehringer Ingelheim International GmbH Binger Strasse 173 55216 Ingelheim am Rhein Germany, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Diabetes

    phase 1 other active

    1 trial
  8. An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Ivacaftor film coated tablets 150 mg of Sun Pharmaceutical Industries Ltd, India with Kalydeco (Ivacaftor) 150 mg film-coated tablets, Marketing Authorisation Holder: Vertex Pharmaceuticals (Ireland) Limited Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland, in healthy adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    Cystic Fibrosis

    phase 1 other active

    1 trial
  9. An open label, balanced, randomized, single dose, two treatment, two period, two sequence, crossover, bioequivalence study comparing Lacosamide tablets USP 200 mg, manufactured by Sun Laboratories Industries Limited, India with Vimpat (Lacosamide) 200 mg film-coated tablets, Marketing Authorisation Holder UCB Pharma S.A., Belgium, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Epileptic seizures

    phase 1 other active

    1 trial
  10. An open label, balanced, randomized, three treatment, three period, three sequence, single dose, crossover study to assess the effect of food and effect of apple sauce on bioavailability of the Test product (Bupropion Hydrochloride Extended Release Capsules 150 mg, manufactured by Sun Pharmaceutical Industries Limited, India) in healthy, adult, human subjects.

    Lacuna Pharma Pty Ltd

    Seasonal affective disorder, Major depressive disorder

    phase 1 other active

    1 trial
  11. An open label, balanced, randomized, two-treatment, four period, two-sequence, multiple-dose (steady-state), fully-replicate crossover bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis

    phase 1 other active

    1 trial
  12. An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial
  13. An open label, balanced, randomized, two-treatment, four-period, two-sequence, single-dose, crossover fully replicate bioequivalence study comparing Mesalamine delayed release capsules 400 mg manufactured by Sun Pharmaceutical Industries Limited, India with Mesalamine Delayed-Release Capsules 400 mg, manufactured for Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, in healthy, adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    ulcerative colitis

    phase 1 other active

    1 trial
  14. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Bosutinib Tablets 100 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with Bosulif (bosutinib) 100 mg, Manufactured and Packed by: Pfizer Manufacturing Deutschland GmbH Betriebsstätte Freiburg Mooswaldallee, Freiburg, Germany, Imported by: Pfizer Brasil Ltda. Rodovia Presidente Castelo Branco, nº32501, km 32.5 CEP 06696-000 – Itapevi – SP, in healthy adult, huma

    Lacuna Pharma Pty Ltd

    myeloid leukemia

    phase 1 other active

    1 trial
  15. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 160 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subject

    Lacuna Pharma Pty Ltd

    Prostate cancer

    phase 1 other active

    1 trial
  16. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Enzalutamide film coated tablets 80 mg, Manufactured for Sun Pharmaceutical Industries Limited, India with XTANDI (Enzalutamide) 80 mg film coated tablets, Made by: Patheon Inc., 2100 Syntex Court, Mississauga, Ontario – Canada, Imported and registered by: Astellas Farma Brasil Importação e Distribuição de Medicamentos Ltda., São Paulo-SP, Brazil, in healthy adult, male subjects

    Lacuna Pharma Pty Ltd

    Prostate cancer

    phase 1 other active

    1 trial
  17. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover bioequivalence study comparing Lamotrigine Dispersible Tablets BP 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Lamictal (Lamotrigine) Dispersible Tablets 100 mg, Manufactured by: Delpharm Poznaÿ – Poland & Registered and Imported by: GlaxoSmithKline Brasil Ltda, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Bipolar disorder, Epilepsy

    phase 1 other active

    1 trial
  18. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose crossover, bioavailability study comparing Bupropion Hydrochloride Extended Release Capsules 150 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with WELLBUTRIN XL (Bupropion hydrochloride) extended release tablets 300 mg, Distributed by: Bausch Health US, LLC Bridgewater, NJ 08807 USA. Manufactured by: Bausch Health Companies, Inc. Steinbach, MB R5G 1Z7, Canada, in healthy, adult, human subjects under

    Lacuna Pharma Pty Ltd

    Seasonal affective disorder, Major depressive disorder

    phase 1 other active

    1 trial
  19. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    plaque psoriasis

    phase 1 other active

    1 trial
  20. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Deucravacitinib tablets 6 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with SOTYKTU (deucravacitinib) tablets 6 mg, Distributed by Bristol-Myers Squibb Company, Princeton, New Jersey 08543 USA, in healthy, adult, human subjects under fed condition

    Lacuna Pharma Pty Ltd

    plaque psoriasis

    phase 1 other active

    1 trial
  21. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study comparing Trametinib tablets 2 mg, Manufactured by Sun Pharmaceutical Industries Limited, India with MEKINIST® (Trametinib) tablets 2 mg, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey 07936, USA in healthy, adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Adjuvant treatment of BRAF V600E or V600K mutation-positive melanoma (in combination with dabrafenib);, BRAF V600E mutation-positive unresectable or metastatic solid tumors;, BRAF V600E mutation-positive metastatic non-small cell lung cancer (NSCLC), in combination with dabrafenib;, BRAF V600E mutation-positive low-grade glioma (LGG)., BRAF V600E mutation-positive locally advanced or metastatic anaplastic thyroid cancer (ATC);, BRAF V600E or V600K mutation-positive unresectable or metastatic melanoma, as a single agent in BRAF-inhibitor treatment-naïve patients or in combination with dabrafenib;

    phase 1 other active

    1 trial
  22. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Brivaracetam Tablets Ph. Eur. 100 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Briviact (brivaracetam) 100 mg film-coated tablets, Marketing Authorisation Holder: UCB Pharma S.A., Allée de la Recherche 60, B-1070 Bruxelles, Belgium; Manufactured by UCB Pharma S.A., Chemin du Foriest, B-1420 Braine-l’Alleud, Belgium, in healthy adult, human subjects und

    Lacuna Pharma Pty Ltd

    Epilepsy

    phase 1 other active

    1 trial
  23. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Clarithromycin tablets 500 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Clarithromycin 500 mg coated tablets Manufactured by: Sanofi Medley Pharmaceuticals Ltd. Brazilian Industry, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Infectious diseases

    phase 1 other active

    1 trial
  24. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of Single Entity Amphetamine Product) 30 mg, manufactured by Frontida Biopharm. Inc., Philadelphia, USA with Attent 30 mg (Mixed Amphetamine Salts tablets) manufactured by Teva Israel Ltd., in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    ADHD

    phase 1 other active

    1 trial
  25. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Imatinib Mesylate Tablets 400 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Glivec® (Imatinib mesylate) Coated tablets 400 mg, Produced by Novartis Pharma Produktions GmbH, Wehr, Germany or Novartis Pharmaceutical Manufacturing LLC, Ljubljana; Imported and Registered by Novartis Biosciences SA, Prof. Vicente Rao Avenue, 90, Sao Paulo – SP, CNPJ: 56.994.

    Lacuna Pharma Pty Ltd

    Acute Lymphoblastic Leukemia (Ph+ ALL), (Ph+) Chronic Myeloid Leukemia

    phase 1 other active

    1 trial
  26. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with VENVANSE (lisdexamfetamine dimesylate) 70 mg Hard Gelatin Capsule, imported and registered by: Takeda Pharma Ltd. Rodovia SP 340 S/N, km 133.5, Ed. Adm. Jaguariúna-SP CNPJ 60.397.775/0001-74 and manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, United States o

    Lacuna Pharma Pty Ltd

    ADHD (Attention Deficit Hyperactivity Disorder), BED (Binge Eating Disorder)

    phase 1 other active

    1 trial
  27. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Lisdexamfetamine Dimesylate capsules 70 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Elvanse (lisdexamfetamine dimesylate) 70 mg hard capsules, Marketing Authorization Holder: Takeda Pharmaceuticals International AG Ireland Branch, Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland, in healthy adult, human subjects under fas

    Lacuna Pharma Pty Ltd

    ADHD

    phase 1 other active

    1 trial
  28. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Maribavir Tablets 200 mg, manufactured by Sun Pharmaceutical Industries Limited, India with LIVTENCITY® (Maribavir) Coated Tablets 200 mg, manufactured by: Catalent CTS, LLC Kansas City, United States of America, packed by: Takeda Ireland Limited Bray, Ireland, imported by: Takeda Pharma Ltda. Highway SP 340 S/N, km 133.5 Jaguariúna Administrative Building -SP CNPJ 60.397.775/

    Lacuna Pharma Pty Ltd

    cytomegalovirus (CMV) infection and/or disease that is refractory (with or without resistance) to one or more prior therapies in adult patients who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT)

    phase 1 other active

    1 trial
  29. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Naltrexone hydrochloride film-coated tablet, 50 mg, manufactured by Sun Pharmaceutical Industries Limited, India with NALTREXONE GH (naltrexone hydrochloride) film-coated tablets 50 mg, Product of Generic Health Pty Ltd Suite 2, Level 2 19-23 Prospect Street Box Hill, VIC, 3128, Australia, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Alcohol dependence

    phase 1 other active

    1 trial
  30. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ponatinib Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Iclusig (Ponatinib hydrochloride) tablets 15 mg, Produced by: Patheon Inc. Mississauga, Canada or Takeda Ireland Limited Bray, Ireland, Imported and registered by: Pint Pharma Medical-Hospital and Pharmaceutical Products Ltd. Nelson Pontes Street, 125, Block 03, Jardim Margarida Zip Code

    Lacuna Pharma Pty Ltd

    chronic myeloid leukemia, Philadelphia chromosome-positive acute lymphoblastic leukemia

    phase 1 other active

    1 trial
  31. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Ruxolitinib Tablets, 20 mg, manufactured by Sun Pharmaceutical Industries Limited, India with JAKAVI (ruxolitinib) tablets 20 mg, (each Jakavi 20 mg tablet contains 26.40 mg of ruxolitinib phosphate equivalent to 20 mg of ruxolitinib). Imported by: Novartis Biociências SA Av. Prof. Vicente Rao, 90 - São Paulo - SP CNPJ: 56.994.502/0001-30. Manufactured by: Novartis Pharma Ste

    Lacuna Pharma Pty Ltd

    Myelofibrosis, polycythemia vera, acute and chronic graft-versus-host-disease.

    phase 1 other active

    1 trial
  32. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Tamsulosin Hydrochloride Capsules USP 0.4 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Tamsulosin Hydrochloride extended-release capsules 0.4 mg, Product of Geolab Indústria Farmacêutica S/A, VP. 1B QD.08-B Modules 01 to 08, DAIA - Anápolis – GO, in healthy adult, human male subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Benign prostatic hyperplasia (BPH)

    phase 1 other active

    1 trial
  33. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Tamsulosin Hydrochloride Capsules USP 0.4 mg, manufactured by Sun Pharmaceutical Industries Limited, India with Tamsulosin Hydrochloride extended-release capsules 0.4 mg, Product of Geolab Indústria Farmacêutica S/A, VP. 1B QD.08-B Modules 01 to 08, DAIA - Anápolis – GO, in healthy adult, human male subjects under fed condition.

    Lacuna Pharma Pty Ltd

    Benign prostatic hyperplasia (BPH)

    phase 1 other active

    1 trial
  34. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fasting condition.

    Lacuna Pharma Pty Ltd

    Rheumatoid arthritis, ulcerative colitis, atopic dermatitis, Crohn's disease, psoriatic arthritis, axial spondyloarthritis

    phase 1 other active

    1 trial
  35. An open label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioequivalence study comparing Upadacitinib Prolonged Release Tablets 15 mg, manufactured by Sun Pharmaceutical Industries Limited, India with RINVOQ 15 mg prolonged-release tablets (Upadacitinib), Marketing Authorization Holder: AbbVie Deutschland GmbH & Co. KG Knollstraße 67061 Ludwigshafen Germany, in healthy adult, human subjects under fed condition.

    Lacuna Pharma Pty Ltd

    Axial spondyloarthritis, Crohn’s disease, Ulcerative colitis, Atopic dermatitis, Rheumatoid arthritis, Psoriatic arthritis

    phase 1 other active

    1 trial
  36. An open label, phase 1 study to evaluate the safety, feasibility and immunogenicity of an allogeneic, cell-based vaccine (VIDIDENCEL) in high grade serous ovarian cancer patients after primary treatment (ALISON)

    Disc Medicine

    High grade serous ovarian cancer

    phase 1 other active

    1 trial
  37. An open label, randomized, crossover, two-period, two-sequence, multiple dose study to assess the relative bioavailability of Rotigotine 4.5 mg (2 mg/24 hrs) transdermal patch (Test Product) compared to Neupro® 2 mg/24 h Transdermal Patch (Reference product) in 48 healthy adult volunteers under fasting conditions.

    Lacuna Pharma Pty Ltd

    Not applicable (submitted trial is a bioavailability study in healthy subjects).

    phase 1 other active

    1 trial
  38. An open label, randomized, crossover, two-period, two-sequence, single dose study to assess the relative bioavailability of Rotigotine 4.5 mg (2 mg/24 hrs) transdermal patch (Test Product) compared to Neupro® 2 mg/24 h Transdermal Patch (Reference product) in 48 healthy adult volunteers under fasting conditions.

    Lacuna Pharma Pty Ltd

    Not applicable (submitted trial is a bioavailability study in healthy subjects).

    phase 1 other active

    1 trial
  39. An open label, randomized, single dose, two-sequence, two-treatment, four-period, fully replicate, cross-over pharmacokinetic study comparing Alverine citrate/Simeticone 60 mg/300 mg soft capsules to Meteospasmyl 60 mg/300 mg soft capsules in healthy male and female subjects under fed conditions.

    Lacuna Pharma Pty Ltd

    Not applicable (submitted trial is a bioavailability study in healthy subjects)

    phase 1 other active

    1 trial
  40. An open, single arm, single-center, Phase 1 trial investigating the effect of 7-days-repeated administration of linaprazan glurate on the pharmacokinetics of repeated doses of an approved antibiotic in healthy participants

    Lacuna Pharma Pty Ltd

    Helicobacter pylori infection, GERD

    phase 1 other active

    1 trial
  41. An open-label Phase 1 study of NEO-PTC-01 in patients with advanced or metastatic melanoma

    BioNTech SE

    Metastatic melanoma

    phase 1 other active

    1 trial
  42. An open-label cocktail drug-drug interaction (DDI) clinical study to assess the effect of multiple oral dosing with leniolisib on the pharmacokinetics (PK) of caffeine, midazolam, rosuvastatin, furosemide, and metformin in healthy subjects

    Pharming Technologies B.V.

    Activated Phosphoinositide 3-Kinase Delta Syndrome

    phase 1 other active

    1 trial
  43. An open-label dose escalation study to estimate maximum tolerated dose (MTD), identify dose-limiting toxicities (DLTs) and study pharmacokinetics following a single dose of intracranially administered temozolomide-based SI-053 as an add-on to the current standard of care (SoC), in adult patients with newly diagnosed glioblastoma (GBM).

    Lacuna Pharma Pty Ltd

    Glioblastoma

    phase 1 other active

    1 trial
  44. An open-label, DDI study to investigate the effects of amlitelimab on the PK of selected cytochrome P450 substrates

    Sanofi-aventis Healthcare Pty Ltd

    Dermatitis atopic

    phase 1 other active

    1 trial
  45. An open-label, prospective, randomised, cross-over trial to assess the pharmacokinetics of an amorphous formulation of sorafenib in mesoporous magnesium carbonate (DPH001) compared to Nexavar® (sorafenib) in healthy volunteers

    Lacuna Pharma Pty Ltd

    Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.

    phase 1 other active

    1 trial
  46. An open-label, prospective, randomised, cross-over trial to assess the pharmacokinetics of an amorphous formulation of sorafenib in mesoporous magnesium carbonate (DPH001) compared to Nexavar® (sorafenib) in healthy volunteers

    Lacuna Pharma Pty Ltd

    Hepatocellular carcinoma, renal cell carcinoma and differentiated thyroid carcinoma.

    phase 1 other active

    1 trial
  47. An open-label, randomized, single-dose, three-way crossover trial to evaluate the pharmacokinetics of nicotine pouch (NP) dry 4 mg compared with Nicorette® lozenge 4 mg in healthy adults who use cigarettes

    Swedish Orphan Biovitrum Pty Ltd

    Nicotine use

    phase 1 other active

    1 trial
  48. An open-label, randomized, single-dose, two-period, two-treatment, crossover bioequivalence study with GP-IMP-001 in healthy male volunteers under fasting conditions.

    Lacuna Pharma Pty Ltd

    inteneded for treatment of - active rheumatoid arthritis in adult patients, - polyarthritic forms of severe, active juvenile idiopathic arthritis, when the response to nonsteroidal anti-inflammatory drugs has been inadequate, - severe recalcitrant disabling psoriasis which is not adequately responsive to other forms of therapy and severe psoriatic arthritis in adult patients, - mild-to-moderate Crohn’s disease, either alone or in combination with corticosteroids, in adult patients refractory or intolerant to thiopurines.

    phase 1 other active

    1 trial

Frequently asked questions

How many Phase I pipeline programs are in the directory?

4,713 published programs match this development stage in our ClinicalTrials.gov index.

What defines this pipeline stage?

Phase and status reflect ClinicalTrials.gov registry fields at last sync. See our clinical trial phases reference for methodology.

Data attribution: Data sources · All pipeline programs