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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
575
Recruiting Now
575
Top Conditions in Phase 1
Advanced Solid Tumor (19) Acute Myeloid Leukemia (19) Solid Tumor (19) Healthy (16) Breast Cancer (15) Advanced Solid Tumors (15) Ovarian Cancer (13) Healthy Volunteers (11) Endometrial Cancer (10) Colorectal Cancer (9)

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

NCT03973268 Phase 1
Recruiting
Mechanism of Action Underlying Ketamine's Antidepressant Effects: The AMPA Throu...
Condition
Depression
Enrollment
70 pts
Location
United States
Sponsor
National Institute of Mental H
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NCT05667649 Phase 1
Recruiting
Autologous Activated Adipose-derived Stem Cells (RB-ADSC) Injected Directly Into...
Condition
Alzheimer Disease
Enrollment
18 pts
Location
United States
Sponsor
Regeneration Biomedical, Inc.
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NCT07158710 Phase 1
Recruiting
Phase I Study of HSK42360 in Malignant Brain Tumors With BRAF V600 Mutation
Condition
Malignant Brain Tumors
Enrollment
159 pts
Location
China
Sponsor
Haisco Pharmaceutical Group Co
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NCT07535606 Phase 1
Recruiting
A Study to Evaluate ALN-4915 in Adult Healthy Volunteers
Condition
Healthy Volunteers
Enrollment
44 pts
Location
United Kingdom
Sponsor
Alnylam Pharmaceuticals
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NCT06949410 Phase 1
Recruiting
HER2 Vaccine for Locally Advanced Breast Cancer
Condition
Breast Cancer
Enrollment
36 pts
Location
United States
Sponsor
Pravin T.P Kaumaya
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NCT07226349 Phase 1
Recruiting
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Ad...
Condition
Advanced Solid Tumor
Enrollment
105 pts
Location
United States, Australia, China
Sponsor
BeOne Medicines
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NCT06585449 Phase 1
Recruiting
A Study to Evaluate ALN-HTT02 in Adult Patients With Huntington's Disease
Condition
Huntington's Disease
Enrollment
66 pts
Location
Canada, Germany, United Kingdom
Sponsor
Alnylam Pharmaceuticals
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NCT07534176 Phase 1
Recruiting
To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of...
Condition
Postmenopause
Enrollment
24 pts
Location
China
Sponsor
Changchun GeneScience Pharmace
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NCT07066657 Phase 1
Recruiting
A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
Condition
Locally Advanced or Metastatic Solid Tumors
Enrollment
572 pts
Location
United States, China
Sponsor
ArriVent BioPharma, Inc.
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NCT06725381 Phase 1
Recruiting
A Phase 1 Study of SKB571 in Subjects With Advanced Solid Tumors
Condition
Solid Malignancies
Enrollment
138 pts
Location
China
Sponsor
Sichuan Kelun-Biotech Biopharm
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NCT05335811 Phase 1
Recruiting
First-in-Human Assessment of Safety, Biodistribution and Pharmacokinetics of 18F...
Condition
Endocrine Neoplasia
Enrollment
55 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT05989347 Phase 1
Recruiting
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadj...
Condition
Breast Cancer
Enrollment
20 pts
Location
United States
Sponsor
Yale University
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NCT07201558 Phase 1
Recruiting
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE P...
Condition
Rheumatoid Arthritis
Enrollment
48 pts
Location
United States, Australia, Belgium
Sponsor
AstraZeneca
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NCT04943848 Phase 1
Recruiting
rHSC-DIPGVax Plus Checkpoint Blockade for the Treatment of Newly Diagnosed DIPG ...
Condition
Diffuse Intrinsic Pontine Glioma
Enrollment
36 pts
Location
United States
Sponsor
Ann & Robert H Lurie Children'
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NCT06790576 Phase 1
Recruiting
Optimizing Transcranial Magnetic Stimulation for Stimulant Use Disorder
Condition
Stimulant Use Disorder
Enrollment
50 pts
Location
United States
Sponsor
University of Minnesota
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NCT06413355 Phase 1
Recruiting
FAPI-74 PET/CT in Adults With Fibrosis
Condition
Fibrosis (Morphologic Abnormality)
Enrollment
45 pts
Location
United States
Sponsor
Abramson Cancer Center at Penn
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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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NCT05432635 Phase 1
Recruiting
Genetically Modified T-cells (CMV-Specific CD19-CAR T-cells) Plus a Vaccine (CMV...
Condition
B-Cell Non-Hodgkin Lymphoma
Enrollment
15 pts
Location
United States
Sponsor
City of Hope Medical Center
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NCT05620290 Phase 1
Recruiting
MRI-Guided Focused Ultrasound Radiosensitization for Patients With Malignant Mel...
Condition
Melanoma
Enrollment
20 pts
Location
Canada
Sponsor
Sunnybrook Health Sciences Cen
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NCT07379684 Phase 1
Recruiting
A Study of Amicidin-β Topical Solution for Patients With Surgical or Traumatic W...
Condition
Surgical Wound Infection
Enrollment
44 pts
Location
United States
Sponsor
Macro Biologics, Inc.
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NCT07704333 Phase 1
Recruiting
Assessment of [18F]-Fluorocellobiose ([18F]FCB) Pharmacokinetics in Healthy Volu...
Condition
Aspergillos
Enrollment
100 pts
Location
United States
Sponsor
National Institutes of Health
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NCT02994433 Phase 1
Recruiting
NMDA Receptor Antagonist Nitrous Oxide Targets Affective Brain Circuits
Condition
Depressive Disorder, Major
Enrollment
60 pts
Location
United States
Sponsor
Washington University School o
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NCT06885710 Phase 1
Recruiting
HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic...
Condition
Chronic Hepatitis b
Enrollment
19 pts
Location
China
Sponsor
Changhai Hospital
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NCT06551584 Phase 1
Recruiting
Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HC...
Condition
Acute Myeloid Leukemia
Enrollment
24 pts
Location
United States
Sponsor
Stanford University
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NCT05687747 Phase 1
Recruiting
Single Centre Prospective Evaluation of 68Gallium-FAPI PET/MRI in Hepatocellular...
Condition
Hepatocellular Carcinoma
Enrollment
100 pts
Location
Singapore
Sponsor
National University Hospital,
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Page 1 of 23 — 575 trials total
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