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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

NCT06024421 Phase 1
Recruiting
Evaluation of Tolerance and Pharmacokinetic Profile of High Doses of Favipiravir...
Condition
Infectious Disease
Enrollment
39 pts
Location
France
Sponsor
Institut National de la Santé
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NCT07371104 Phase 1
Recruiting
Bioequivalence Study of DWZ2501 in Patients With Advanced BRCA-mutated High-grad...
Condition
Cancer
Enrollment
40 pts
Location
South Korea
Sponsor
Daewoong Pharmaceutical Co. LT
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NCT04387916 Phase 1
Recruiting
A Study of KC1036 in Patients with Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
207 pts
Location
China
Sponsor
Beijing Konruns Pharmaceutical
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NCT06494371 Phase 1
Recruiting
A Study of LCAR-HL30 in Subjects With Relapsed/Refractory Hodgkin's Lymphoma and...
Condition
Hodgkin's Lymphoma
Enrollment
32 pts
Location
China
Sponsor
Ruijin Hospital
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NCT03968406 Phase 1
Recruiting
Talazoparib and Radiation Therapy in Treating Patients With Locally Recurrent Gy...
Condition
Malignant Female Reproductive System Neoplasm
Enrollment
24 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT05296304 Phase 1
Recruiting
A Study of Bexarotene Combined With Radiotherapy in People With Mycosis Fungoide...
Condition
Cutaneous T-cell Lymphoma
Enrollment
20 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance
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NCT05039411 Phase 1
Recruiting
Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Tr...
Condition
Perianal Fistula Due to Crohn's Disease
Enrollment
5 pts
Location
Malaysia
Sponsor
CryoCord Sdn Bhd
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NCT06620809 Phase 1
Recruiting
The Safety and Efficacy of NouvSoma001 in Neuromyelitis Optica Spectrum Disorder...
Condition
Neuromyelitis Optica Spectrum Disorders
Enrollment
69 pts
Location
China
Sponsor
Tongji Hospital
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NCT06112093 Phase 1
Recruiting
Repetitive Transcranial Magnetic Stimulation for Post-concussion Headaches
Condition
Brain Concussion
Enrollment
60 pts
Location
United States
Sponsor
State University of New York -
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NCT06351904 Phase 1
Recruiting
A Study of RAG-01 in Patients With Non-muscle-invasive Bladder Cancer (NMIBC) Wh...
Condition
Non-Muscle-Invasive Bladder Cancer (NMIBC)
Enrollment
72 pts
Location
Australia
Sponsor
Ractigen Therapeutics.
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NCT06996704 Phase 1
Recruiting
A Clinical Study of AK0610
Condition
Healthy Volunteer Study
Enrollment
136 pts
Location
China
Sponsor
Shanghai Ark Biopharmaceutical
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NCT03729752 Phase 1
Recruiting
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
Condition
HIV-1-infection
Enrollment
30 pts
Location
United States
Sponsor
University of California, San
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NCT07016152 Phase 1
Recruiting
An Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogeni...
Condition
Klebsiella Pneumoniae Infection
Enrollment
40 pts
Location
Taiwan
Sponsor
Cho Pharma Inc.
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NCT06384352 Phase 1
Recruiting
A Phase I Study to Evaluate the Safety,Tolerability, Pharmacokinetics, and Effic...
Condition
Advanced Solid Tumors
Enrollment
155 pts
Location
United States, Australia, Canada
Sponsor
MediLink Therapeutics (Suzhou)
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NCT07587047 Phase 1
Recruiting
Adia Med of Winter Park LLC Lower Back Pain Research Study
Condition
Chronic Mechanical Lower Back Pain
Enrollment
100 pts
Location
United States
Sponsor
Adia Med of Winter Park LLC
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NCT04500847 Phase 1
Recruiting
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
Condition
Alzheimer Disease, Early Onset
Enrollment
35 pts
Location
United States
Sponsor
Butler Hospital
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NCT02966665 Phase 1
Recruiting
: Vascular Function in Health and Disease
Condition
Chronic Obstructive Pulmonary Disease
Enrollment
420 pts
Location
United States
Sponsor
Russell Richardson
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NCT07513207 Phase 1
Recruiting
A Study in Healthy People to Test How Vicadrostat Affects the Heart
Condition
Healthy
Enrollment
45 pts
Location
Germany
Sponsor
Boehringer Ingelheim
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NCT06660381 Phase 1
Recruiting
Psilocybin-assisted Treatment for Cannabis Use Disorder
Condition
Cannabis Use Disorder
Enrollment
12 pts
Location
United States
Sponsor
Johns Hopkins University
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NCT07668557 Phase 1
Recruiting
Anti-CD33-CLL1 CAR-T Cells (ICG415) for the Treatment of Relapsed/Refractory Acu...
Condition
Acute Myeloid Leukemia (AML)
Enrollment
18 pts
Location
China
Sponsor
iCell Gene Therapeutics
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NCT06607003 Phase 1
Recruiting
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety...
Condition
Malaria
Enrollment
300 pts
Location
United States
Sponsor
National Institute of Allergy
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NCT07522970 Phase 1
Recruiting
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinet...
Condition
Healthy Volunteers
Enrollment
100 pts
Location
China
Sponsor
LinGang Laboratory
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NCT06120283 Phase 1
Recruiting
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast ...
Condition
Advanced Solid Tumor
Enrollment
399 pts
Location
United States, Australia, Brazil
Sponsor
BeOne Medicines
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NCT06148272 Phase 1
Recruiting
A Study of LY3971297 in Healthy Participants
Condition
Healthy
Enrollment
225 pts
Location
United States, Japan, Singapore
Sponsor
Eli Lilly and Company
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NCT07554222 Phase 1
Recruiting
Study to Evaluate the Safety, Tolerability and How IBI3013 is Taken up and Proce...
Condition
Healthy
Enrollment
160 pts
Location
China
Sponsor
Innovent Biologics (Suzhou) Co
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Page 2 of 25 — 611 trials total
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