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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 first-in-human study to learn about how safe BAY 3375968 is, how it moves into, through, and out of the body, and to find its best dose when given alone or with pembrolizumab in participants with advanced solid tumors

    Bayer AG

    Advanced solid tumors

    phase 1 other active

    1 trial

  2. A first-in-human study to learn about how safe BAY 3620122 is, how much of it gets absorbed in the blood, and how it affects the body of healthy participants

    Bayer AG

    Vasodilatory shock

    phase 1 other active

    1 trial

  3. A first-in-human study to learn about how safe the study drug is in healthy participants

    Bayer AG

    Cardiac arrhythmia

    phase 1 other active

    1 trial

  4. A first-in-human study to learn about the safety of BAY 3547926 and how well it works in participants with advanced liver cancer

    Bayer AG

    hepatocellular carcinoma (HCC)

    phase 1 other active

    1 trial

  5. A first-in-human study to learn how safe the study treatment BAY2862789 is, to find the best dose, how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, and how it acts on different tumors in participants with advanced solid tumors

    Bayer AG

    Advanced solid tumors, Non-small cell lung cancer

    phase 1 other active

    1 trial

  6. A first-in-human trial to evaluate safety, tolerability, and pharmacokinetics of single and multiple oral doses of Debio 1453P in healthy adults

    Alphapharm Pty Ltd

    Sexual Transmitted Infection (STI)

    phase 1 other active

    1 trial

  7. A first-in-human, randomized, double-blind, placebo-controlled, three-part study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics of BP1.15205 after single and repeated oral ascending doses, including the BP1.15205 effect on cardiac repolarization, as well as an exploratory assessment of the food effect on the pharmacokinetics of BP1.15205 in healthy participants

    Bioprojet Pharma

    Narcolepsy

    phase 1 other active

    1 trial

  8. A first-in-human, randomized, participant and investigator blinded, placebo-controlled single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of HJB647 in healthy participants and otherwise healthy participants with elevated blood pressure, with an open-label CYP3A inhibitor drug-drug interaction part

    Novartis Pharmaceuticals

    Heart failure (HF)

    phase 1 other active

    1 trial

  9. A multicentric, open-label, non-randomized study to evaluate the pharmacokinetic, safety and tolerability of ITF2357 given as an oral single 50 mg dose in participants with chronic hepatic impairment relative to matched participants with normal hepatic function.

    Italfarmaco S.p.A.

    Participants with normal hepatic function, Participants with moderate HI, Participants with mild HI

    phase 1 other active

    1 trial

  10. A phase 1 multi-centre, randomized, single-blind, steady-state study to evaluate pharmacokinetics, pharmacodynamics, safety and tolerability after multiple-dose administration of three different doses of naronapride in patients with moderate idiopathic or diabetic gastroparesis compared to healthy subjects

    Dr. Falk Pharma GmbH

    Idiopathic or diabetic gastroparesis

    phase 1 other active

    1 trial

  11. A phase 1 study of FluBHPVE6E7 immunotherapy in patients with HPV16-associated oropharyngeal squamous cell carcinoma

    Blue Earth Diagnostics Ireland Ltd

    Treatment of human papilloma virus (HPV) associated infections and cancers

    phase 1 other active

    1 trial

  12. A phase 1 study of GSK2857916 + Standard of Care (SOC) in first line multiple myeloma patients (DREAMM-9)

    GlaxoSmithKline

    Multiple Myeloma

    phase 1 other active

    1 trial

  13. A phase 1 study of oral Debio 0123 in combination with carboplatin in patients with advanced solid tumors

    Alphapharm Pty Ltd

    Patients with tumors

    phase 1 other active

    1 trial

  14. A phase 1 study to assess the mass balance, pharmacokinetics, metabolism, and excretion of GSBR-1290, containing a microtracer dose of [14C] GSBR-1290, in healthy participants

    Structure Therapeutics

    Not applicable - Healthy volonteers

    phase 1 other active

    1 trial

  15. A phase 1 trial to evaluate the safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity of VIS171 in participants with autoimmune disease(s)

    Otsuka Beijing Research Institute

    Systemic lupus erythematosus, Immune-mediated focal segmental glomerulosclerosis, Alopecia Areata

    phase 1 other active

    1 trial

  16. A phase 1, Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt (EYP651) and Evaluation of Potential Drug-Drug Interactions.

    Lacuna Pharma Pty Ltd

    Healthy volunteers, Impaired renal function and suspected MASH

    phase 1 other active

    1 trial

  17. A phase 1, randomised, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics in healthy adult subjects after subcutaneous injection of TISA-818-Inj-5mg/mL.

    Lacuna Pharma Pty Ltd

    Idiopathic pulmonary fibrosis

    phase 1 other active

    1 trial

  18. A phase 1, randomized, double-blind, single-center, placebo-controlled first-in-human trial to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of RBD7007 in healthy participants

    Lacuna Pharma Pty Ltd

    Complement-mediated diseases

    phase 1 other active

    1 trial

  19. A phase I dose finding study of oral TNO155 in adult patients with advanced solid tumors

    Novartis Pharmaceuticals

    Advanced solid tumors

    phase 1 other active

    1 trial

  20. A phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients with solid tumors

    Novartis Pharmaceuticals

    Locally advanced unresectable or metastatic colorectal cancer (CRC), Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC), Locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC), Locally advanced unresectable or metastatic soft tissue sarcoma (excluding GIST and Kaposi sarcoma), Locally advanced unresectable or metastatic HR+/HER2- ductal or lobular breast cancer (BC), Locally advanced unresectable or metastatic triple negative breast cancer (TNBC)

    phase 1 other active

    1 trial

  21. A phase I study investigating the local tolerability and pharmacokinetics of isoniazid (INH) inhalation by wet nebulization in patients with tuberculosis

    Disc Medicine

    Tuberculosis

    phase 1 other active

    1 trial

  22. A phase I study of [177Lu]Lu-EVS459 in patients with ovarian and lung cancers

    Novartis Pharmaceuticals

    Advanced high-grade serous ovarian cancer (OC), Locally advanced unresectable or metastatic non-squamous non-small cell lung carcinoma (NSCLC)

    phase 1 other active

    1 trial

  23. A phase I study of [68Ga]Ga-DWJ155 in patients with advanced breast and NSCLC cancers

    Novartis Pharmaceuticals

    Advanced breast cancer and advanced NSCLC

    phase 1 other active

    1 trial

  24. A phase I study to evaluate the safety and preliminary signs of efficacy of [177Lu]Lu-OncoFAP-23 alone and in combination with L19-IL2 as a treatment of metastatic FAP-positive solid tumors.

    Philogen S.p.A.

    Patients with advanced/metastatic FAP-positive tumors

    phase 1 other active

    1 trial

  25. A phase I trial of IMA970A plus Montanide in combination with Durvalumab (anti-PD-L1) in patients with very early, early and intermediate stage of hepatocellular carcinoma after any standard treatments.

    Fondazione Telethon ETS

    Hepatocellular carcinoma

    phase 1 other active

    1 trial

  26. A phase I, open-label, multi-center study of KFA115 as a single agent and in combination with pembrolizumab in patients with select advanced cancers

    Novartis Pharmaceuticals

    Thymic Carcinoma, Nasopharyngeal Cancer, Anal Cancer, Head and Neck Squamous Cell Carcinoma, Epithelial Ovarian Cancer, Cutaneous melanoma, Mesothelioma, Non-small cell lung cancer, Esophagogastric Cancer, Triple negative breast cancer, Microsatellite Instability High Colorectal Cancer, Clear Cell Renal Cell Carcinoma

    phase 1 other active

    1 trial

  27. A phase Ib, open-label, ascending dose study to assess safety, tolerability and pharmacokinetics of PIT565 in participants with rheumatoid arthritis (RA)

    Novartis Pharmaceuticals

    Rheumatoid Arthritis

    phase 1 other active

    1 trial

  28. A phase Ib, open-label, ascending dose study with step-up doses to assess safety, tolerability, and pharmacokinetics of PIT565 in participants with systemic lupus erythematosus (SLE)

    Novartis Pharmaceuticals

    Systemic Lupus Erythematosus

    phase 1 other active

    1 trial

  29. A pilot, open label, single dose, randomized, four-period, four-sequence, four-treatment crossover, comparative bioavailability study of UDCA PMCS 500 mg formulation 1 film-coated tablets (test 1 formulation), and UDCA PMCS 500 mg formulation 2 film-coated tablets (test 2 formulation), and UDCA PMCS 500 mg formulation 3 film-coated tablets (test 3 formulation), and reference formulation in healthy, male and female volunteers under fasting conditions.

    s.r.o.

    UDCA causes a reduction in cholesterol saturation of the bile by inhibiting cholesterol absorption in the intestine and reducing cholesterol secretion into the bile. Presumably, cholesterol gallstones are gradually dissolved by dispersion of the cholesterol and formation of liquid crystals.

    phase 1 other active

    1 trial

  30. A placebo-controlled safety and tolerability study of intravenous (IV) and subcutaneous (SC) AZD1163 in healthy volunteers

    AstraZeneca AB

    Rheumatoid Arthritis

    phase 1 other active

    1 trial

  31. A positron emission tomography study of synaptic nerve cells proteins alpha-7 nicotinic acetylcholine receptors in brain of healthy volunteers and patients with mild cognitive impairment and Alzheimer´s disease.

    The George Institute

    Alzheimer´s disease

    phase 1 other active

    1 trial

  32. A randomised, assessor-blinded, controlled, healthy volunteer, Phase I study to assess skin irritation and sensitization potential of a novel 5% lidocaine medicated plaster

    The George Institute

    None. Healthy subjects

    phase 1 other active

    1 trial

  33. A randomised, double-blind, placebo-controlled phase Ib trial evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of ACD856 in healthy participants

    Lacuna Pharma Pty Ltd

    Depression, Cognitive dysfunction, Alzheimer’s disease

    phase 1 other active

    1 trial

  34. A randomised, double-blind, placebo-controlled trial to assess the effects of EP395 following an inhaled endotoxin challenge in healthy adults

    Lacuna Pharma Pty Ltd

    Healthy volunteers [targeted indication: chronic obstructive pulmonary disease (COPD)]

    phase 1 other active

    1 trial

  35. A randomised, open-label, 5-period, cross-over trial to assess the pharmacokinetics and safety of 3 oral solid formulations of buloxibutid (C21) in healthy male and female participants

    Lacuna Pharma Pty Ltd

    Idiopahtic pulmonary fibrosis

    phase 1 other active

    1 trial

  36. A randomised, open-label, parallel group study to compare the pharmacokinetics and pharmacodynamics of NEODIDRO® 0.266 mg vs DIBASE® 25,000 IU oral doses in male and female patients.

    Verona Pharma Ireland Limited

    Patients with low Vitamin D plasma level

    phase 1 other active

    1 trial

  37. A randomised, open-label, single-centre, drug-drug-interaction trial to evaluate the impact of carboxylesterase 2 (CES2)- and CYP3A4-inhibition on the pharmacokinetics of buloxibutid in healthy volunteers

    Lacuna Pharma Pty Ltd

    Idiopathic pulmonary fibrosis

    phase 1 other active

    1 trial

  38. A randomized double-blind placebo-controlled phase 1 study on the safety, tolerability and pharmacokinetics/-dynamics of escalating single intravenous doses of AK1967 (Procizumab) in healthy male volunteers

    Lacuna Pharma Pty Ltd

    Circulatory shock

    phase 1 other active

    1 trial

  39. A randomized, Phase 1b, single-center, observer-blind, active-controlled study to evaluate the safety, immunogenicity, and immunological mechanisms of one single administration of TETRALITE influenza vaccine at two dose levels of LiteVax Adjuvant, in healthy participants aged 60 years and older and in healthy participants aged 18 to 50 years.

    Teva Pharma GmbH

    Influenza

    phase 1 other active

    1 trial

  40. A randomized, Phase I, single-center, observer-blind, active-controlled study to evaluate the safety, tolerability and immunogenicity of one single administration of PCV-LITE, a novel adjuvanted pneumococcal conjugate vaccine at one dose level of LiteVax Adjuvant, in healthy participants aged 18-50 years.

    Teva Pharma GmbH

    Pneumococcal infection

    phase 1 other active

    1 trial

  41. A randomized, double-blind, placebo-controlled, single and multiple-dose-escalation, phase 1 study in healthy volunteers and patients with ulcerative colitis to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of GRT-001 (MONOlith trial)

    Rani Therapeutics Holdings

    Ulcerative colitis

    phase 1 other active

    1 trial

  42. A randomized, investigator masked pilot study to establish the experimental conditions and select the criteria to compare topical application of 2 methyl aminolevulinate creams: evaluation of protoporphyrin IX formation in the skin of healthy subjects.

    Substipharm

    None - Healthy subjects

    phase 1 other active

    1 trial

  43. A randomized, open-label, single dose, 2-way crossover bioequivalence study comparing apixaban 5 mg hard capsules (PG412 [Celon Pharma]) vs apixaban 5 mg film-coated tablets (Eliquis [Bristol-Myers Squibb]) under fasting conditions in healthy volunteers

    Lacuna Pharma Pty Ltd

    Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

    phase 1 other active

    1 trial

  44. A randomized, open-label, single dose, cross-over study to evaluate the drug-drug interaction between Proscar 5 mg, film-coated tablets and Cialis 5 mg film-coated tablets when co-administered versus the administration of each product alone in healthy volunteers under fasting conditions. Study no. FIN-TAD-DDI-03-24

    Lacuna Pharma Pty Ltd

    healthy male subjects

    phase 1 other active

    1 trial

  45. A randomized, single dose, cross-over bioavailability study comparing the drug-drug interaction between telmisartan tablets, indapamide tablets, and amlodipine tablets when co-administered versus the administration of each product alone in three arms to healthy volunteers under fasting conditions.

    s.r.o.

    high blood pressure

    phase 1 other active

    1 trial

  46. A randomized, single dose, cross-over, replicated, open-label bioequivalence study comparing indacaterol/glycopyrronium (85/43mcg inhalation powder hard capsules) (PG341 [Celon Pharma] vs Ultibro Breezhaler [Novartis])

    Lacuna Pharma Pty Ltd

    Maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD)

    phase 1 other active

    1 trial

  47. A randomized, single-blind, placebo-controlled, study to examine the safety, tolerability, and pharmacokinetics of M6229 administered as a 120-hour continuous infusion at two dose levels versus placebo in healthy subjects

    Lacuna Pharma Pty Ltd

    Sepsis and Septic Shock

    phase 1 other active

    1 trial

  48. A randomized, single-center, double-blind, placebo-controlled, first-in-human trial with single and multiple ascending doses to determine safety, tolerability, and pharmacokinetics of GRT7040 in healthy volunteers

    Gruenenthal GmbH

    Treatment of pain

    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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