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Intelligence Β· 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.

Top sponsors

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  1. 9MW3811 injection

    Shanghai University of Traditional Chinese Medicine

    Pulmonary Fibrosis

    phase 1 small molecule completed

    1 trial

  2. 9vHPV Vaccine plus BCG Vaccine Mix for percutaneous use

    Lxo Ireland Designated Activity Company

    HPV Infection

    phase 1 mab active

    1 trial

  3. A Clinical Study to Assess the Safety, Tolerability of JNJ-63733657 and to evaluate how fast and to what extent JNJ-63733657 reaches the bloodstream and is absorbed, modified and removed from the body when administered as a Subcutaneous Infusion Using a Syringe Pump and as an Intravenous Infusion in Healthy Adult Participants

    Janssen-Cilag International N.V.

    Alzheimer's Disease (Healthy Participants)

    phase 1 other active

    1 trial

  4. A Clinical Study to Compare the Impact of Multiple-dose Oral Administration of Macitentan, 10 mg versus 75 mg on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Healthy Participants

    Lacuna Pharma Pty Ltd

    Pulmonary Arterial Hypertension

    phase 1 other active

    1 trial

  5. A Clinical Study to Compare the Impact of Multiple-dose Oral Administration of Macitentan, 10 mg versus 75 mg on Endothelin-1 Clearance, Endothelial Function, and Hemodynamics in Healthy Participants

    Lacuna Pharma Pty Ltd

    Pulmonary Arterial Hypertension

    phase 1 other active

    1 trial

  6. A Clinical Study to Evaluate the Safety and Pharmacokinetics of JNJ- 73841937 (Lazertinib), a Third Generation EGFR-TKI, as Monotherapy or in Combinations With JNJ-61186372, a Human Bispecific EGFR and cMet Antibody in Participants With Advanced Non-Small Cell Lung Cancer

    Janssen-Cilag International N.V.

    Advanced Non-Small Cell Lung Cancer

    phase 1 other active

    1 trial

  7. A Clinical Trial to Assess the Safety of SOR102 in Healthy Participants and Patients with Ulcerative Colitis

    Lacuna Pharma Pty Ltd

    Ulcerative colitis

    phase 1 other active

    1 trial

  8. A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTIPLE RISING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF DEURUXOLITINIB IN HEALTHY ADULTS

    Lacuna Pharma Pty Ltd

    alopecia areata

    phase 1 other active

    1 trial

  9. A Dose Finding Study of [177Lu]Lu-DOTA-TATE in Newly Diagnosed Glioblastoma in Combination with Standard of Care and in Recurrent Glioblastoma as a Single Agent.

    Novartis Pharmaceuticals

    Glioblastoma

    phase 1 other active

    1 trial

  10. A Double-Blind, Randomized, Three-arm, Active-Controlled, Parallel-Group, Phase 1 Study Evaluating Pharmacokinetic Similarity of Three Formulations of Pembrolizumab (CT-P51, EU-approved Keytruda, and US-licensed Keytruda) as Adjuvant Therapy in Patients with Completely Resected Stage IIB, IIC, and III Melanoma

    Celltrion Healthcare Australia Pty Ltd

    Completely Resected Stage IIB, IIC, and III Melanoma

    phase 1 other active

    1 trial

  11. A Double-blind, Placebo-controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Effect of Steady-state AZD6793 on the Steady-state Pharmacokinetics/Pharmacodynamics of Metformin in Participants with Type 2 Diabetes Mellitus

    AstraZeneca AB

    Type 2 Diabetes Mellitus

    phase 1 other active

    1 trial

  12. A First In Human Phase I Trial Evaluating safety, tolErability and ResponSe of [211At]At-Girentuximab (ATO-101β„’) in PatiEnts with Non-Muscle-InVasive BladdER CANCEr Refractory to Standard Treatment (PERSEVERANCE EU)

    CERO THERAPEUTICS HOLDINGS, INC.

    Non-Muscle-Invasive Bladder Cancer (NMIBC) refractory

    phase 1 other active

    1 trial

  13. A First in Human Study to Assess Safety, Tolerability and Pharmacokinetics of a single dose of REGN22044 in Healthy Adults

    Lacuna Pharma Pty Ltd

    Heathy volunteer trial

    phase 1 other active

    1 trial

  14. A First-in-Human Study of KK2223 in Participants with T-cell Non-Hodgkin Lymphoma

    KYOWA KIRIN AUSTRALIA PTY LTD

    T-cell Non-Hodgkin Lymphoma, Cutaneous T-cell lymphoma (CTCL), Peripheral T-cell lymphoma (PTCL)

    phase 1 other active

    1 trial

  15. A First-in-Human Study to Evaluate the Safety and Anti-cancer Activity of the product FS120, which is an Antibody medication, to be administered alone or with Pembrolizumab in Subjects with Advanced Malignancies

    Lacuna Pharma Pty Ltd

    Advanced Malignancies

    phase 1 other active

    1 trial

  16. A First-in-Human Study to Evaluate the Safety and Anti-cancer Activity of the product FS222, which is an Antibody medication, in Subjects with Advanced Malignancies

    Lacuna Pharma Pty Ltd

    Advanced Malignancies

    phase 1 other active

    1 trial

  17. A First-in-Human Study to Evaluate the Safety and Tolerability of ALN-APP in Patients with EOAD

    Alnylam Netherlands B.V.

    Early-onset Alzheimer's disease (EOAD)

    phase 1 other active

    1 trial

  18. A First-in-Human Study to Test the Safety and Effects of the Investigational Drug IPH4502 in People with Advanced Cancers

    Lacuna Pharma Pty Ltd

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  19. A First-in-Human, randomised, double blind, placebo-controlled, single ascending dose trial to evaluate safety, tolerability, and pharmacokinetics of APC148 in healthy adults.

    Lacuna Pharma Pty Ltd

    Urinary tract infections (UTIs)/complicated UTI (cUTI)

    phase 1 other active

    1 trial

  20. A First-in-human study to learn how safe the study drug BAY2965501 is, find the best dose (single drug & combination), how it affects the body, what maximum amount can be given, how it moves into, through and out of the body, how it acts on different tumors in participants with advanced solid tumors

    Bayer AG

    Advanced solid tumors

    phase 1 other active

    1 trial

  21. A Long-Term Follow-up Study for Subjects Previously Treated with A Century Therapeutics Cellular Therapy Product

    Century Therapeutics

    Hematological or solid tumor malignancies or autoimmune diseases

    phase 1 other active

    1 trial

  22. A Mass Balance Study of [14C]-IPN60250 in Healthy Adult Participants

    Ipsen

    Primary sclerosing cholangitis (PSC)

    phase 1 other active

    1 trial

  23. A Multi-arm Phase 1b Study of Talquetamab With Other Anticancer Therapies in Participants with Multiple Myeloma

    Janssen-Cilag International N.V.

    multiple myeloma

    phase 1 other active

    1 trial

  24. A Multi-arm Phase 1b Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma

    Janssen-Cilag International N.V.

    Relapsed/Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  25. A Multicenter, Open-Label, Phase 1a/b First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BG-C0979 in Patients with Selected Advanced Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  26. A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT

    Fondazione Telethon ETS

    High-Risk, Surgically Resectable Melanoma

    phase 1 other active

    1 trial

  27. A Multiple-Ascending-Dose Study of MK-1708 in Healthy Participants

    Merck Sharp and Dohme

    Amyotrophic lateral sclerosis and Alzheimer’s disease

    phase 1 other active

    1 trial

  28. A PET Study to Assess the Occupancy of M4 Muscarinic Acetylcholine Receptors by BMS-986521 in Healthy Adult Participants

    Bristol-Myers Squibb Australia Pty Ltd

    Neuropsychiatric indications and potentially other conditions

    phase 1 other active

    1 trial

  29. A PHASE 1 TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PK, AND PD of AX-0810 IN HEALTHY PARTICIPANTS

    ProQR Therapeutics N.V.

    Cholestatic liver disease

    phase 1 other active

    1 trial

  30. A PHASE 1, OPEN-LABEL, DOSE ESCALATION AND DOSE EXPANSION STUDY OF CLN-049 FOR THE TREATMENT OF ACUTE MYELOID LEUKEMIA (AML) PATIENTS WITH MEASURABLE RESIDUAL DISEASE (MRD)

    Cullinan Therapeutics

    Acute Myeloid Leukemia (AML) with Measurable Residual Disease (MRD)

    phase 1 other active

    1 trial

  31. A PHASE 1, OPEN-LABEL, SINGLE-DOSE MASS BALANCE AND METABOLITE PROFILING STUDY OF 14C-LABELED IZICOPAN (INF904) IN HEALTHY MALE PARTICIPANTS

    InflaRx GmbH

    Not applicable, healthy volunteers

    phase 1 other active

    1 trial

  32. A PHASE I, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE ASCENDING, SINGLE-DOSE STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND IMMUNOGENICITY OF RAY121 IN HEALTHY VOLUNTEERS

    Lacuna Pharma Pty Ltd

    Nervous System disease

    phase 1 other active

    1 trial

  33. A Participant- and Investigator--Blinded, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants with Chronic Kidney Disease

    Novartis Pharmaceuticals

    Chronic Kidney Disease

    phase 1 other active

    1 trial

  34. A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an anti-PD-1 Monoclonal Antibody, in Patients with Advanced Solid Tumors

    TESARO Bio Netherlands B.V.

    Patients with Advanced Solid Tumors

    phase 1 other active

    1 trial

  35. A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)

    Lacuna Pharma Pty Ltd

    Non-muscle Invasive Bladder Cancer

    phase 1 other active

    1 trial

  36. A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination with Anticancer Agents in Participants with Selected Advanced Solid Tumors

    GlaxoSmithKline

    Neoplasms

    phase 1 other active

    1 trial

  37. A Phase 1 First-in-Human Study of the Safety and Effects of VIR-5818 Alone or with Pembrolizumab in Participants with Advanced or Metastatic HER2-Expressing Cancers

    Vir Biotechnology

    Participants with Locally Advanced or Metastatic HER2-Expressing Cancers

    phase 1 other active

    1 trial

  38. A Phase 1 Open-Label Mass Balance clinical trial to Investigate the Absorption, Metabolism, and Excretion of Single Oral Administration of [14C]-TEV-56286 Following Multiple Oral Administrations of Nonlabeled TEV-56286 to Healthy Male Participants.

    Lacuna Pharma Pty Ltd

    Healthy participant

    phase 1 other active

    1 trial

  39. A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications

    AbbVie Deutschland GmbH & Co. KG

    locally advanced or metastatic solid tumors

    phase 1 other active

    1 trial

  40. A Phase 1 Open-Label, Safety, Pharmacokinetic and Preliminary Efficacy Study of STRO-002, an Anti-Folate Receptor alpha (FolRΞ±) Antibody Drug Conjugate (ADC), in Combination with Bevacizumab in Patients with Advanced Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers)

    SUTRO BIOPHARMA, INC.

    Advanced Epithelial Ovarian Cancer (including Fallopian Tube or Primary Peritoneal cancers)

    phase 1 other active

    1 trial

  41. A Phase 1 Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PAS-004, a MEK (1/2) Inhibitor, in Patients with MAPK Pathway-driven Advanced Solid Tumors with a Documented RAS, NF1, or RAF Mutation or Patients who have Failed BRAF/MEK Inhibition

    Pasithea Therapeutics

    Solid Tumors

    phase 1 other active

    1 trial

  42. A Phase 1 Open-label Study to Evaluate the Safety and Efficacy of MK‑8294 Monotherapy in Advanced Solid Tumors

    Merck Sharp and Dohme

    Breast Cancer, Cervical squamous cell carcinoma, Endometrial Carcinoma, Esophageal squamous cell carcinoma, Head and neck squamous cell carcinoma, Bladder Cancer

    phase 1 other active

    1 trial

  43. A Phase 1 Randomized Study to Evaluate the Effect of Food on the Bioavailability of BMS-986158 in Participants with Advanced Solid Tumors.

    Bristol-Myers Squibb Australia Pty Ltd

    Advanced Solid Tumors

    phase 1 other active

    1 trial

  44. A Phase 1 Randomized, Open Label Pharmacokinetic Comparability Study Comparing Pre- and Post-change Teclistamab in Participants with Relapsed/Refractory Multiple Myeloma

    Janssen-Cilag International N.V.

    Relapsed/Refractory Multiple Myeloma

    phase 1 other active

    1 trial

  45. A Phase 1 Randomized, Placebo-Controlled, Double-Blind Study of the Safety, Tolerability and Pharmacological Effects of PT00114 in Healthy Volunteers

    Protagenic Therapeutics, Inc.new

    Phase I study in healthy male and female volunteers. Intended indication: mood disorders

    phase 1 other active

    1 trial

  46. A Phase 1 Safety and Dose Finding Study of 131I -TLX101 Plus Standard of Care in Patients with Newly Diagnosed Glioblastoma

    Lacuna Pharma Pty Ltd

    Glioblastoma multiforme (GBM)

    phase 1 other active

    1 trial

  47. A Phase 1 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Tarlatamab in Subjects With Small Cell Lung Cancer (DeLLphi-300)

    Amgen

    Small Cell Lung Cancer

    phase 1 other active

    1 trial

  48. A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BGB-B2033, Alone or in Combination With Tislelizumab With or Without Bevacizumab, in Participants With Selected Advanced or Metastatic Solid Tumors

    BEONE MEDICINES AUS PTY LTD

    Selected Advanced or Metastatic Solid Tumors

    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 Β· All pipeline programs

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