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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
Advanced Solid Tumor (29) Solid Tumor (21) Advanced Solid Tumors (19) Healthy (15) Healthy Volunteers (13) Healthy Volunteer (12) Colorectal Cancer (11) Triple Negative Breast Cancer (11) Solid Tumors (10) Ovarian Cancer (10)

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

NCT07444268 Phase 1
Recruiting
How [14C]-DSP-5336 is Absorbed, Broken Down, and Removed From the Body After a S...
Condition
Advanced Hematologic Malignancies
Enrollment
8 pts
Location
United States
Sponsor
Sumitomo Pharma America, Inc.
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NCT06376474 Phase 1
Recruiting
To Evaluate the Pharmacokinetics of Hemay005 Tablets in Subjects With Liver Dama...
Condition
Psoriasis
Enrollment
24 pts
Location
China
Sponsor
Ganzhou Hemay Pharmaceutical C
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NCT06066424 Phase 1
Recruiting
Phase 1 Dose Escalation and Expansion Study of TROP2 CAR Engineered IL15-transdu...
Condition
Solid Tumors
Enrollment
54 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT07226817 Phase 1
Recruiting
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on ...
Condition
Healthy Volunteers
Enrollment
140 pts
Location
United States
Sponsor
Bristol-Myers Squibb
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NCT07086768 Phase 1
Recruiting
Dose-Escalation and Dose-Expansion Study of BSI-082 Monotherapy and Combined The...
Condition
Solid Tumor
Enrollment
57 pts
Location
United States
Sponsor
Lei Zheng
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NCT05843448 Phase 1
Recruiting
IDO and PD-L1 Peptide Based Immune-Modulatory Therapeutic (IO102-IO103) in Combi...
Condition
High Risk Non-Muscle Invasive Bladder Urothelial Carcinoma
Enrollment
30 pts
Location
United States
Sponsor
University of California, Davi
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NCT07390955 Phase 1
Recruiting
A Study of Safety and Drug Levels of ePGT121v1-LS, PGDM1400LS, and VRC07-523LS i...
Condition
HIV
Enrollment
83 pts
Location
United States, Peru, Zimbabwe
Sponsor
National Institute of Allergy
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NCT07486115 Phase 1
Recruiting
A Study to Test How Different Doses of BI 3814916 Are Tolerated by Healthy Peopl...
Condition
Healthy
Enrollment
136 pts
Location
Belgium
Sponsor
Boehringer Ingelheim
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NCT06688435 Phase 1
Recruiting
A Study to Evaluate the Safety and Preliminary Efficacy of SYS6020 CAR T-cells i...
Condition
Myasthenia Gravis
Enrollment
50 pts
Location
China
Sponsor
CSPC ZhongQi Pharmaceutical Te
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NCT07069725 Phase 1
Recruiting
The Phase 1, Open-label, PET Trial Designed to Investigate the Effect of AZD2389...
Condition
Liver Fibrosis
Enrollment
12 pts
Location
Sweden
Sponsor
AstraZeneca
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NCT06826768 Phase 1
Recruiting
A Ph Ib Study of REGN5678 Plus Cemiplimab in Patients With mCRPC
Condition
Prostate Cancer
Enrollment
60 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT07525791 Phase 1
Recruiting
A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills an...
Condition
Overweight
Enrollment
45 pts
Location
United States
Sponsor
Novo Nordisk A/S
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NCT07417488 Phase 1
Recruiting
GUCY2C Prime-Boost Vaccination for Advanced Colorectal and Small Bowel Adenocarc...
Condition
Colorectal Cancer
Enrollment
18 pts
Location
United States
Sponsor
Thomas Jefferson University
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NCT04428671 Phase 1
Recruiting
Cemiplimab Before and After Surgery for the Treatment of High Risk Cutaneous Squ...
Condition
Metastatic Skin Squamous Cell Carcinoma
Enrollment
20 pts
Location
United States
Sponsor
Emory University
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NCT05445804 Phase 1
Recruiting
Oral Cannabidiol for Tobacco Cessation
Condition
Tobacco Use
Enrollment
50 pts
Location
United States
Sponsor
Johns Hopkins University
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NCT07384052 Phase 1
Recruiting
Safety and Feasibility of Intranasal Insulin in Patients With Spinal Cord Injury
Condition
Spinal Cord Injury
Enrollment
12 pts
Location
United States
Sponsor
HealthPartners Institute
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NCT06061549 Phase 1
Recruiting
Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure Wit...
Condition
Heart Failure, Diastolic
Enrollment
10 pts
Location
United States
Sponsor
Sardocor Corp.
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NCT06327685 Phase 1
Recruiting
Avapritinib With Decitabine in Patients With SM-AHN
Condition
Systemic Mastocytosis With an Associated Hematologic Neoplasm
Enrollment
34 pts
Location
United States
Sponsor
H. Lee Moffitt Cancer Center a
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NCT07205198 Phase 1
Recruiting
A Clinical Trial of SIBP-A10 Injection in the Treatment of Advanced Malignant Tu...
Condition
Advanced Tumors
Enrollment
160 pts
Location
China
Sponsor
Shanghai Institute Of Biologic
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NCT07262333 Phase 1
Recruiting
A Trial of Hydroxynidone Capsules in Single-dose Administration for Patients Wit...
Condition
Renal Insufficiency Chronic
Enrollment
56 pts
Location
China
Sponsor
Beijing Continent Pharmaceutic
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NCT05528887 Phase 1
Recruiting
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematologica...
Condition
Relapsed/Refractory Hematological Malignancies
Enrollment
10 pts
Location
China
Sponsor
The Affiliated People's Hospit
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NCT06307249 Phase 1
Recruiting
Precision Therapy for Solid Tumors: Synergistic CDK4/6 Inhibition and Anti-VEGF ...
Condition
Cancer
Enrollment
50 pts
Location
Lebanon
Sponsor
Lebanese University
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NCT07344558 Phase 1
Recruiting
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MNKD-201 in Pat...
Condition
Idiopathic Pulmonary Fibrosis (IPF)
Enrollment
24 pts
Location
United States
Sponsor
Mannkind Corporation
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NCT04319848 Phase 1
Recruiting
Safety and Efficacy of Tissue Engineered Endothelial Keratoplasty
Condition
Mild to Moderate Corneal Endothelial Decompensation
Enrollment
30 pts
Location
Singapore
Sponsor
Singapore Eye Research Institu
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NCT07596693 Phase 1
Recruiting
KXV01 Injection in Patients With Advanced Solid Tumor (Including Osteosarcoma an...
Condition
Advanced Solid Tumors
Enrollment
30 pts
Location
China
Sponsor
TCRx Therapeutics Co.Ltd
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