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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
589
Recruiting Now
589
Top Conditions in Phase 1
Advanced Solid Tumors (25) Advanced Solid Tumor (21) Healthy (18) Solid Tumor (16) Breast Cancer (14) Acute Myeloid Leukemia (13) Ovarian Cancer (13) Solid Tumors (12) Healthy Volunteers (11) Healthy Participants (11)

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

NCT07439263 Phase 1
Recruiting
Single Ascending Dose Study of HB2198 in Healthy Participants
Condition
Healthy Volunteer
Enrollment
32 pts
Location
Australia
Sponsor
Hinge Bio
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NCT07437105 Phase 1
Recruiting
Dose Escalation Study Evaluating the Safety and Pharmacokinetics of VX-272 in He...
Condition
Cystic Fibrosis
Enrollment
160 pts
Location
United States
Sponsor
Vertex Pharmaceuticals Incorpo
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NCT06241456 Phase 1
Recruiting
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibod...
Condition
Advanced Solid Tumor
Enrollment
351 pts
Location
United States
Sponsor
Fate Therapeutics
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NCT06264219 Phase 1
Recruiting
Restoration of the Gut Microbiome After Cesarean Section
Condition
Microbial Colonization
Enrollment
80 pts
Location
Denmark
Sponsor
Jakob Stokholm
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NCT06170294 Phase 1
Recruiting
MAGE-A4-directed TCR-T in the Treatment Amongst Subjects With Advanced Solid Tum...
Condition
Advanced Solid Tumor
Enrollment
20 pts
Location
China
Sponsor
Peking University
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NCT06094556 Phase 1
Recruiting
An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanc...
Condition
Advanced Solid Tumors
Enrollment
240 pts
Location
China
Sponsor
Suzhou Suncadia Biopharmaceuti
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NCT07225439 Phase 1
Recruiting
Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatm...
Condition
Non Hodgkin Lymphoma
Enrollment
15 pts
Location
United States
Sponsor
Paolo Caimi, MD
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NCT07501039 Phase 1
Recruiting
A Phase 1 Study of BLKR201 in Healthy Adult Participants
Condition
Healthy
Enrollment
128 pts
Location
United States
Sponsor
Formation Bio, Inc.
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NCT06238401 Phase 1
Recruiting
An Open-label, Multi-center, Dose-escalation and Cohort Expansion Phase I/IIa Cl...
Condition
Advanced Solid Tumors
Enrollment
77 pts
Location
China
Sponsor
Hangzhou Adcoris Biopharmacy C
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NCT05885412 Phase 1
Recruiting
A Phase 1, Dose Escalation Trial of RP-A601 in Subjects With PKP2 Variant-Mediat...
Condition
PKP2 Arrhythmogenic Cardiomyopathy (PKP2-ACM)
Enrollment
9 pts
Location
United States
Sponsor
Rocket Pharmaceuticals Inc.
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NCT05591027 Phase 1
Recruiting
Safety and Target Engagement of Centella Asiatica in Cognitive Impairment
Condition
Mild Cognitive Impairment
Enrollment
48 pts
Location
United States
Sponsor
Oregon Health and Science Univ
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NCT07793266 Phase 1
Recruiting
ICG Fluorescence in Knee Arthroscopy Study
Condition
To Assess the Feasibility, Visualization Capability, and Optimal Dosing of ICG Fluorescence Imaging for Intraoperative Assessment of Knee Tissue Perfusion
Enrollment
40 pts
Location
United States
Sponsor
Henry Ford Health System
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NCT07020156 Phase 1
Recruiting
A First-in-Human Phase I Trial of OX118 in Healthy Volunteers
Condition
Immune System
Enrollment
32 pts
Location
Sweden
Sponsor
Oxion Biologics AB
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NCT07610941 Phase 1
Recruiting
Phase 1 Open Label Trial of MST-0312 Alone and in Combination in Subjects With S...
Condition
Cancer-Neoplasms
Enrollment
157 pts
Location
Spain
Sponsor
Mestag Therapeutics Limited
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NCT07328451 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodyna...
Condition
Alzheimer Disease, Early Onset
Enrollment
68 pts
Location
Netherlands, United Kingdom
Sponsor
Denali Therapeutics Inc.
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NCT05490888 Phase 1
Recruiting
Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirr...
Condition
Cirrhosis, Liver
Enrollment
74 pts
Location
United States
Sponsor
PharmaIN
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NCT07153172 Phase 1
Recruiting
Safety Follow-up Study of Participants Dosed With INV-347 in Study INV-CL-108
Condition
Obesity
Enrollment
91 pts
Location
Canada
Sponsor
Novo Nordisk A/S
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NCT06639503 Phase 1
Recruiting
Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau
Condition
Tibial Plateau Fractures
Enrollment
38 pts
Location
United States
Sponsor
University of Chicago
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NCT04429542 Phase 1
Recruiting
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therap...
Condition
Head and Neck Squamous Cell Carcinoma
Enrollment
473 pts
Location
United States, Australia, Canada
Sponsor
Bicara Therapeutics
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NCT07453862 Phase 1
Recruiting
Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
Condition
Restless Leg Syndrome (RLS)
Enrollment
20 pts
Location
China
Sponsor
Beijing Friendship Hospital
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NCT06827470 Phase 1
Recruiting
Establishing a Controlled Human Infection Model of Pertactin-deficient Bordetell...
Condition
Pertussis (Whooping Cough)
Enrollment
60 pts
Location
Canada
Sponsor
Dalhousie University
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NCT07082803 Phase 1
Recruiting
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
Condition
Lymphoma
Enrollment
180 pts
Location
United States, Australia, Canada
Sponsor
Treeline Biosciences, Inc.
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NCT07368127 Phase 1
Recruiting
A Study of TPD3310 in Patients With Advanced Malignant Tumors
Condition
Advanced Malignant Solid Tumors
Enrollment
112 pts
Location
China
Sponsor
TAIBIDI PHARMACEUTICAL TECHNOL
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NCT07656454 Phase 1
Recruiting
A Study Understanding How Much CDR132L Enters the Bloodstream After Injection Un...
Condition
Healthy Volunteers
Enrollment
32 pts
Location
Germany
Sponsor
Novo Nordisk A/S
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NCT06904066 Phase 1
Recruiting
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Partic...
Condition
Malignancy, Hematologic
Enrollment
86 pts
Location
United States
Sponsor
National Cancer Institute (NCI
View Trial →
Page 2 of 24 — 589 trials total
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