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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. A Phase I Study of Belantamab Mafodotin in Multiple Myeloma Participants with Normal and Impaired Hepatic Function

    GlaxoSmithKline

    Relapsed or Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  2. A Phase I Study of Belantamab Mafodotin in Multiple Myeloma Participants with Normal and Impaired Renal Function

    GlaxoSmithKline

    Relapsed/Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  3. A Phase I Study of RO7589831 in Participants with Advanced Solid Tumors

    Hoffmann-La Roche

    Advanced solid tumors

    phase 1 other active

    1 trial

  4. A Phase I Study to Evaluate Safety and Immunogenicity of DNA Vaccine N-pVAX1 against Crimean Congo Hemorrhagic Fever (CCHF-NP-1)

    The George Institute

    Crimean Congo Hemorrhagic Fever

    phase 1 other active

    1 trial

  5. A Phase I study of IDH305 in patients with advanced malignancies that harbor IDH1R132 mutations

    Novartis Pharmaceuticals

    Advanced malignancies that harbor IDH1R132 mutations

    phase 1 other active

    1 trial

  6. A Phase I study of STA551 and STA551 in combination with atezolizumab in patients with solid tumours

    Lacuna Pharma Pty Ltd

    Locally advanced or metastatic solid tumors

    phase 1 other active

    1 trial

  7. A Phase I study to evaluate the Safety, Tolerability, and Pharmacokinetics of BAL2420 in Healthy Adult Subjects

    Lacuna Pharma Pty Ltd

    Severe infections caused by Gram-negative bacteria

    phase 1 other active

    1 trial

  8. A Phase I study to evaluate the safety and dosimetry of 68Ga-OncoACP3 in patients with prostate cancer

    Philogen S.p.A.

    Patients with prostate cancer with: -suspected metastasis who are candidates for initial definitive therapy -suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL) -metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands

    phase 1 other active

    1 trial

  9. A Phase I study to evaluate the safety and dosimetry of 68Ga-OncoCAIX in patients with CAIX-positive cancer

    Philogen S.p.A.

    Patients with suspected clear cell renal cell carcinoma (ccRCC)

    phase 1 other active

    1 trial

  10. A Phase I study to evaluate the safety and dosimetry of imaging with 68Ga-OncoACP3 in prostate cancer.

    Philogen S.p.A.

    Patients with prostate cancer with: - suspected metastasis who are candidates for initial definitive therapy - suspected recurrence based on elevated serum prostate-specific antigen (PSA) level (i.e., a progressive and confirmed serum PSA level > 0.2 ng/mL) - metastatic disease who might be candidates for treatment with 177Lu-labelled PSMA ligands

    phase 1 other active

    1 trial

  11. A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.

    Philogen S.p.A.

    Advanced solid tumors, specifically: • metastatic clear cell renal carcinoma • proficient mismatch repair / microsatellite stable (pMMR/MSS), BRAF-V600E-mutant negative colorectal carcinoma • locally advanced or metastatic pancreatic adenocarcinoma

    phase 1 other active

    1 trial

  12. A Phase I trial to investigate the pharmacokinetics and ECG effects of single doses of linaprazan glurate administered as oral tablets to healthy participants

    Lacuna Pharma Pty Ltd

    Erosive Gastroesophageal Reflux Disease (eGERD)

    phase 1 other active

    1 trial

  13. A Phase I, First In Human, open-label study of escalating doses of INA03 administered intravenously as single agent in adult patients with relapse/refractory Acute Leukemia

    The George Institute

    Relapse/ refractory acute Leukemia

    phase 1 other active

    1 trial

  14. A Phase I, Open-Label Study of CLN-978 in Patients with Treatment-Refractory Rheumatoid Arthritis (RA)

    Cullinan Therapeutics

    Treatment-Refractory Rheumatoid Arthritis

    phase 1 other active

    1 trial

  15. A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients with Relapsed or Refractory Lymphoma

    Hutchmed Europe B.V.

    Lymphoma

    phase 1 other active

    1 trial

  16. A Phase I, Open-label, Multi-center, First-in-human Trial to Investigate E303, in Participants with Advanced Refractory Solid Tumors

    Samsung Bioepis NL B.V.

    advanced refractory solid tumors

    phase 1 other active

    1 trial

  17. A Phase I, Open-label, Randomized, Active-Controlled, to Evaluate the Safety and Immunogenicity of the DuoChol Oral Cholera Vaccine in 18 to 45 years old Healthy Participants in Sweden.

    The George Institute

    Prevention of Cholera disease

    phase 1 other active

    1 trial

  18. A Phase I, Randomised, Investigator- and Participant-blinded, Placebo-Controlled, Study to Assess the Safety, Tolerability, and Pharmacodynamics of AZD4144 in Participants with Obesity.

    AstraZeneca AB

    Cardiorenal disease

    phase 1 other active

    1 trial

  19. A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg (Haleon) to assess Bioequivalence with Alvedon 500 mg Film-Coated Tablet (Haleon, Sweden) and Panadol 500 mg Film-Coated Tablet (Haleon, Australia) in Healthy Adult Subjects Under Fasting Conditions

    HALEON AUSTRALIA PTY LTD

    Healthy volunteers, therapeutic indication not studied

    phase 1 other active

    1 trial

  20. A Phase I, Randomized, Partial Double-blind, Single dose, 3-Way Cross-over Study to Assess the Lung Exposure Bioequivalence of Budesonide, Glycopyrronium, and Formoterol for BGF MDI HFO Compared with BGF MDI HFA Using an AeroChamber Plus Flow-Vu Spacer and to Compare the Lung Exposure of BGF MDI HFO with a Spacer to BGF MDI HFO without a Spacer

    AstraZeneca AB

    Not applicable, healthy volunteers

    phase 1 other active

    1 trial

  21. A Phase I, open-label study in healthy adults comparing the availability in the body of the active substance lidocaine following administration of 2% and 4% lidocaine gel into the urethra

    Lacuna Pharma Pty Ltd

    bioavailability trial with healthy participants, therapeutic indication not studied

    phase 1 other active

    1 trial

  22. A Phase I, open-label, non-randomized study to assess the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LTP001 following a single oral dose of [14C]LTP001 in healthy male participants

    Novartis Pharmaceuticals

    Healthy volunteers

    phase 1 other active

    1 trial

  23. A Phase I, open-label, non-randomized study to evaluate the absorption, distribution, metabolism and excretion and pharmacokinetics of DLX313 (minzasolmin) following a single oral dose of [14C]DLX313 in healthy male participants

    Novartis Pharmaceuticals

    Parkinson’s Disease

    phase 1 other active

    1 trial

  24. A Phase I, randomized, controlled, Latin-square, open-label study, to evaluate the effect of ADV7103 on gastric pH under fed and fasting conditions in adult healthy participants.

    Advicenne S.A.

    distal renal tubular acidosis (dRTA)

    phase 1 other active

    1 trial

  25. A Phase I/IIa Clinical Trial to Assess the Safety, Tolerability, and Efficacy of a Single Intravitreal Injection of SPVN20 Gene Therapy in Participants with Advanced Rod Cone Dystrophy

    Pari Pharma GmbH

    End-stage rod-cone dystrophy

    phase 1 other active

    1 trial

  26. A Phase IB Study to determine efficacy and safety of Durvalumab and/or novel anti-cancer agents, with or without chemotherapy, in patients with previously untreated NSCLC

    AstraZeneca AB

    Metastatic Non-Small Cell Lung Cancer (NSCLC)

    phase 1 other active

    1 trial

  27. A Phase Ib, Multicentre, Randomised, Single-blind, Parallel-group, Placebo-controlled, Study to Characterise the Pharmacokinetics and Pharmacodynamics of AZD4604 Administered via the Turbuhaler® Device in Adults with Mild Asthma

    AstraZeneca AB

    Asthma

    phase 1 other active

    1 trial

  28. A RANDOMIZED PHASE I, DOUBLE-BLIND, PARALLEL, COMPARATIVE ASSESSMENT OF PHARMACOKINETICS, SAFETY, PHARMACODYNAMICS, AND IMMUNOGENICITY OF LT-01 (AN OMALIZUMAB BIOSIMILAR CANDIDATE [TEST]) LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION VERSUS EU-APPROVED XOLAIR® LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION (REFERENCE) IN HEALTHY SUBJETCS: CIMA STUDY.

    Laboratorios Tillomed Spain S.L.U

    Chronic spontaneous urticaria, Allergic asthma, Chronic rhinosinusitis with nasal polyps

    phase 1 other active

    1 trial

  29. A RANDOMIZED, DOUBLE-BLIND, THREE-PART, TWO-PERIOD, TWO-SEQUENCE, SINGLE-DOSE, CROSS-OVER STUDY TO COMPARE THE PHARMACOKINETICS (PK), SAFETY AND IMMUNOGENICITY PROFILE OF MB04 (PROPOSED ETANERCEPT BIOSIMILAR), EU-SOURCED ENBREL® AND US-LICENSED ENBREL® IN HEALTHY MALE VOLUNTEERS.

    Mabxience Research SL

    Not applicable, Healthy Volunteers

    phase 1 other active

    1 trial

  30. A Randomized Study in Healthy Participants to Identify the Optimal Subcutaneous Injection Strategy for COR-1167

    Lacuna Pharma Pty Ltd

    Chronic Heart Failure

    phase 1 other active

    1 trial

  31. A Randomized, Blinded, Placebo-Controlled Dose-Ranging Phase 1b Study of the Safety, Pharmacokinetics, and Antiviral Activity of ABI-4334 in Subjects with Chronic Hepatitis B Virus Infection

    ASSEMBLY BIOSCIENCES, INC.

    chronic hepatitis B virus infection (cHBV)

    phase 1 other active

    1 trial

  32. A Randomized, Multiple-Dose, Open-Label, Parallel-Group Study to Evaluate the Pharmacokinetic Profiles of LY03010 and the Relative Bioavailability at Steady-State of LY03010 versus XEPLION® in Patients with Schizophrenia

    Lacuna Pharma Pty Ltd

    Schizophrenia

    phase 1 other active

    1 trial

  33. A SINGLE-ARM, OPEN-LABEL, PHASE I STUDY TO DETERMINE THE SAFETY, TOLERABILITY, AND PRELIMINARY EFFICACY OF OBE-CEL IN PARTICIPANTS WITH REFRACTORY PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS

    Autolus GmbH

    Refractory Progressive Multiple Sclerosis

    phase 1 other active

    1 trial

  34. A SINGLE-CENTER, OPEN-LABEL, TWO-PERIOD STUDY TO INVESTIGATE THE EFFECT OF MULTIPLE DOSE ITRACONAZOLE, A STRONG CYP3A INHIBITOR, ON THE PHARMACOKINETICS OF A SINGLE 30 MG DOSE OF RO7269162 IN HEALTHY PARTICIPANTS

    Hoffmann-La Roche

    Not applicable, healthy volunteers

    phase 1 other active

    1 trial

  35. A SINGLE-CENTER, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF REPEAT DOSES OF ARM210 IN HEALTHY SUBJECTS.

    Lacuna Pharma Pty Ltd

    Cardiac arrhythmias

    phase 1 other active

    1 trial

  36. A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF COR-1389

    Lacuna Pharma Pty Ltd

    Obesity / Right heart failure (healthy participants)

    phase 1 other active

    1 trial

  37. A Single Ascending Dose, Single-Centre Study, to Assess Pharmacokinetics, Safety and Tolerability of a Single Intramuscular Dose of Bedaquiline Long-Acting Injection Formulation in Healthy Participants

    Janssen-Cilag International N.V.

    Tuberculosis

    phase 1 other active

    1 trial

  38. A Single Dose, Fast state, Crossover Replicate Bioequivalence Study of NITROFURANTOIN 100 mg prolonged-release capsules (IASIS PHARMA) vs.FURABID® 100 mg prolonged-release capsules (Amdipharm Limited)

    Lacuna Pharma Pty Ltd

    healthy subjects

    phase 1 other active

    1 trial

  39. A Single Dose, Non-randomised, Open-label, Parallel Group Study to Assess the Pharmacokinetics, Safety, and Tolerability of AZD4144 in Participants with Severe Renal Impairment, End-stage Kidney Disease, and in Healthy Participants

    AstraZeneca AB

    Healthy Volunteers, Renal Impairment and End Stage Kidney Disease

    phase 1 other active

    1 trial

  40. A Single-Arm, Open-Label, Phase 1 Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients with Severe, Refractory Systemic Lupus Erythematosus

    Autolus GmbH

    Severe, Refractory Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  41. A Single-Ascending-Dose Study of MK6916 in Healthy Participants

    Merck Sharp and Dohme

    Acute and chronic Pain

    phase 1 other active

    1 trial

  42. A Single-Dose Pharmacokinetic Study of Eloralintide in Participants with Varying Degrees of Liver Impairment and Participants with Normal Liver Function

    Eli Lilly Co.

    Participants with Mild, Moderate, or Severe Hepatic Impairment and Participants with Normal Hepatic Function

    phase 1 other active

    1 trial

  43. A Single-Dose Pharmacokinetic Study of Lepodisiran in Participants with Varying Degrees of Liver Impairment and Participants with Normal Liver Function

    Eli Lilly Co.

    Normal Hepatic Function and Mild, Moderate, or Severe Hepatic Impairment

    phase 1 other active

    1 trial

  44. A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants with Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

    AbbVie Deutschland GmbH & Co. KG

    Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia

    phase 1 other active

    1 trial

  45. A Study Evaluating Venetoclax in Combination With Azacitidine in Participants With Treatment-Naïve Higher-Risk Myelodysplastic Syndromes (MDS)

    AbbVie Deutschland GmbH & Co. KG

    Myelodysplastic Syndromes (MDS)

    phase 1 other active

    1 trial

  46. A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients with Metastatic Colorectal Cancer (INTRINSIC)

    Hoffmann-La Roche

    Metastatic Colorectal Cancer

    phase 1 other active

    1 trial

  47. A Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of Forimtamig in Participants With Relapsed or Refractory Multiple Myeloma

    Hoffmann-La Roche

    Relapsed or Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  48. A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)

    Hoffmann-La Roche

    Diffuse large B-cell lymphoma (DLBCL), Grade 3B follicular lymphoma, High grade B-cell lymphoma (HGBL), Epstein-Barr virus−positive DLBCL

    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

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