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Phase 1 Clinical Trials
Phase 1 trials test a new drug or treatment in a small group (20–80 people) for the first time. The primary goal is to evaluate safety, determine a safe dosage range, and identify side effects.
Total Trials
611
Recruiting Now
611
Top Conditions in Phase 1
Frequently Asked Questions — Phase 1 Trials
What is tested in a Phase 1 clinical trial?
Phase 1 trials test a new drug or treatment in a small group of 20–80 people for the first time. The primary goals are to evaluate safety, determine a safe dosage range, identify side effects, and study how the drug is metabolized and excreted. Phase 1 trials typically enroll patients with the target condition who have exhausted standard treatment options, or healthy volunteers in some cases.
How long do Phase 1 clinical trials last?
Phase 1 trials typically last several months to one year depending on the drug, dose-escalation protocol, and follow-up period. The relatively small patient cohort and focused safety objectives make Phase 1 the shortest stage in clinical development. Some are extended into Phase 1/2 combined designs to simultaneously gather early efficacy signals.
Are Phase 1 clinical trials safe to join?
Phase 1 trials are the first human tests of a new intervention and carry the most uncertainty about safety. All Phase 1 studies must be approved by an Institutional Review Board (IRB) and operate under strict FDA oversight. Participants receive intensive monitoring throughout the study. While risks exist, Phase 1 protocols use conservative dosing and frequent safety assessments to protect participants.
Active Phase 1 Studies
NCT03809351 Phase 1
Recruiting
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
Condition
Alzheimer Disease
Enrollment
160 pts
Location
United States
Sponsor
University of Alabama at Birmi
NCT05018767 Phase 1
Recruiting
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell...
Condition
Frailty
Enrollment
86 pts
Location
Antigua and Barbuda, Greece, Slovenia
Sponsor
The Foundation for Orthopaedic
NCT04704271 Phase 1
Recruiting
Gender Related Differences in the Acute Effects of Delta-9-Tetrahydrocannabinol ...
Condition
Cannabis
Enrollment
100 pts
Location
United States
Sponsor
Yale University
NCT05774509 Phase 1
Recruiting
Treatment of Non-ischemic Cardiomyopathies by Intravenous Extracellular Vesicles...
Condition
Heart Failure With Reduced Ejection Fraction
Enrollment
12 pts
Location
France
Sponsor
Assistance Publique - Hôpitaux
NCT04323748 Phase 1
Recruiting
Dose Dense Rituximab for High Risk Newly Diagnosed Acute Immune Thrombocytopenic...
Condition
Immune Thrombocytopenic Purpura
Enrollment
20 pts
Location
United States
Sponsor
New York Medical College
NCT07347678 Phase 1
Recruiting
Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharm...
Condition
High Cholesterol
Enrollment
60 pts
Location
Australia
Sponsor
Ikaria Bioscience Pty Ltd
NCT04872478 Phase 1
Recruiting
Pharmacokinetic and Safety Study of MRX-2843 in Adolescents and Adults With Rela...
Condition
Acute Myeloid Leukemia
Enrollment
50 pts
Location
United States
Sponsor
Meryx, Inc.
NCT06355232 Phase 1
Recruiting
Covid-19 and Influenza Oral Vaccine Study
Condition
covid19 Infection
Enrollment
100 pts
Location
Australia
Sponsor
Vaxine Pty Ltd
NCT06481852 Phase 1
Recruiting
A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibilit...
Condition
Pulmonary Arterial Hypertension
Enrollment
24 pts
Location
United States
Sponsor
University of Minnesota
NCT07215078 Phase 1
Recruiting
Study About Whether Atirmociclib/PF-07220060 Proportionally Increases Exposure a...
Condition
Healthy Volunteer
Enrollment
72 pts
Location
United States
Sponsor
Pfizer
NCT07232758 Phase 1
Recruiting
Safety, Tolerability and Pharmacokinetic Studies of HRS-2183 for Injection in He...
Condition
Chinese Healthy Adult Subjects
Enrollment
42 pts
Location
China
Sponsor
Jiangsu HengRui Medicine Co.,
NCT06792734 Phase 1
Recruiting
Phase 1 Trial of BTM-3566 in Relapsed/Refractory Mature B Cell Lymphomas
Condition
Lymphoma, B-Cell
Enrollment
24 pts
Location
United States
Sponsor
Bantam Pharmaceuticals
NCT05752552 Phase 1
Recruiting
Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Adva...
Condition
Adult Solid Tumor
Enrollment
55 pts
Location
Belgium, France, Netherlands
Sponsor
DeuterOncology
NCT05504278 Phase 1
Recruiting
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-s...
Condition
Advanced Non-Small Cell Lung Cancer
Enrollment
144 pts
Location
China
Sponsor
Innovent Biologics (Suzhou) Co
NCT07490236 Phase 1
Recruiting
Trilaciclib in Combination With Chemotherapy in Patients With CDK4/6-Dependent S...
Condition
Trilaciclib
Enrollment
100 pts
Location
China
Sponsor
Hebei Medical University Fourt
NCT05800665 Phase 1
Recruiting
A Study Evaluating the Safety, Pharmacokinetics, and Activity of RO7656594 In Pa...
Condition
Advanced Prostate Cancer
Enrollment
210 pts
Location
United States, Australia, Canada
Sponsor
Genentech, Inc.
NCT05702463 Phase 1
Recruiting
Assessing Pharmacokinetics and Pharmacodynamics of Daily Enteric-coated Aspirin ...
Condition
Platelet Aggregation
Enrollment
30 pts
Location
Canada
Sponsor
Montreal Heart Institute
NCT06329206 Phase 1
Recruiting
A Phase Ia/Ib Study of GH2616 Tablet in Subjects With Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
156 pts
Location
China
Sponsor
Suzhou Genhouse Bio Co., Ltd.
NCT06625593 Phase 1
Recruiting
A First-in-Human (FIH) Study of BG-C137, an Anti-Fibroblast Growth Factor Recept...
Condition
Advanced Solid Tumor
Enrollment
168 pts
Location
United States, Australia, China
Sponsor
BeOne Medicines
NCT06994949 Phase 1
Recruiting
Assessing CSF Flow Dynamics in Pediatric Hemorrhagic Hydrocephalus
Condition
Post-hemorrhagic Hydrocephalus (PHH)
Enrollment
20 pts
Location
United States
Sponsor
Eva Sevick
NCT06246071 Phase 1
Recruiting
A Study of TYK-00540 in Adult Patients With Solid Tumors
Condition
Locally Advanced or Metastatic Solid Tumors
Enrollment
156 pts
Location
China
Sponsor
TYK Medicines, Inc
NCT07250633 Phase 1
Recruiting
Pharmacokinetic Study of Vorasidenib in Severe Hepatically Impaired and Matched-...
Condition
Severe Hepatic Impairment
Enrollment
20 pts
Location
United States
Sponsor
Institut de Recherches Interna
NCT06592638 Phase 1
Recruiting
A Phase 1 Dose Escalation Study of ZG006 in Patients With Small Cell Lung Cancer
Condition
Small Cell Lung Cancer
Enrollment
30 pts
Location
United States
Sponsor
Suzhou Zelgen Biopharmaceutica
NCT06562192 Phase 1
Recruiting
Phase I Study of [177Lu]Lu-NNS309 in Patients With Pancreatic, Lung, Breast and ...
Condition
Pancreatic Ductal Adenocarcinoma
Enrollment
162 pts
Location
United States, Belgium, Canada
Sponsor
Novartis Pharmaceuticals
NCT06263998 Phase 1
Recruiting
Clinical Study for the Evaluation of Safety and Tolerability of NCP112 Eye Drops
Condition
Xerophthalmia
Enrollment
60 pts
Location
South Korea
Sponsor
Huons Co., Ltd.
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