Browse by Phase
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
NCT05030298 Phase 1
Recruiting
Preoperative Radiosurgery for the Treatment of High Grade Glioma, NeoGlioma Tria...
Condition
Malignant Glioma
Enrollment
28 pts
Location
United States
Sponsor
Mayo Clinic
NCT06619587 Phase 1
Recruiting
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Sing...
Condition
Solid Tumor
Enrollment
410 pts
Location
United States, Australia, Canada
Sponsor
Genentech, Inc.
NCT06326021 Phase 1
Recruiting
Optimised CD33 (FL-33) CAR T Therapy for Refractory/Relapsed Acute Myeloid Leuka...
Condition
Refractory/Relapsed Acute Myeloid Leukaemia
Enrollment
27 pts
Location
China
Sponsor
Beijing GoBroad Hospital
NCT07098806 Phase 1
Recruiting
Multiple Dose Intraventricular Administration of Rhenium-186 NanoLiposome for Le...
Condition
Leptomeningeal Metastasis
Enrollment
24 pts
Location
United States
Sponsor
Plus Therapeutics
NCT04064359 Phase 1
Recruiting
Safety and Preliminary Efficacy of OBT076 in Recurrent/Metastatic CD205+ Solid T...
Condition
Solid Tumor
Enrollment
200 pts
Location
United States, Belgium, France
Sponsor
Oxford BioTherapeutics Ltd
NCT00004847 Phase 1
Recruiting
Diagnosis of Pheochromocytoma
Condition
Pheochromocytoma
Enrollment
3,000 pts
Location
United States
Sponsor
Eunice Kennedy Shriver Nationa
NCT07416552 Phase 1
Recruiting
A Study to Investigate CEA-PRIT 2.0 in Participants With Metastatic Colorectal C...
Condition
Metastatic Colorectal Cancer
Enrollment
180 pts
Location
United States
Sponsor
Hoffmann-La Roche
NCT07020533 Phase 1
Recruiting
A Vaccine (CMV-MVA Triplex Vaccine) for the Enhancement of CMV-Specific Immunity...
Condition
Accelerated Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Enrollment
46 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT06696846 Phase 1
Recruiting
CD70-CAR-NK Cell Therapy for T Cell Lymphoma and Acute Myeloid Leukemia
Condition
Relapsed/Refractory T-cell Lymphoma
Enrollment
25 pts
Location
China
Sponsor
Second Affiliated Hospital, Sc
NCT06636123 Phase 1
Recruiting
GZ17-6.02 in Advanced CRPC After Progression on Anti-Androgen Therapy
Condition
Castration-resistant Prostate Cancer
Enrollment
30 pts
Location
United States
Sponsor
Virginia Commonwealth Universi
NCT07625423 Phase 1
Recruiting
Intratumoral Injection of Recombinant Human Endostatin Adenovirus (EDS01) for th...
Condition
Head & Neck Cancer
Enrollment
9 pts
Location
China
Sponsor
West China Hospital
NCT05101213 Phase 1
Recruiting
Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered G...
Condition
Adenovirus Infection
Enrollment
30 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT05003960 Phase 1
Recruiting
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell...
Condition
Autism
Enrollment
15 pts
Location
Antigua and Barbuda, Greece
Sponsor
The Foundation for Orthopaedic
NCT06257355 Phase 1
Recruiting
Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in...
Condition
Corneal Scar
Enrollment
20 pts
Location
United States
Sponsor
Claris Biotherapeutics, Inc.
NCT03918408 Phase 1
Recruiting
Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linkin...
Condition
Keratoconus, Unstable
Enrollment
300 pts
Location
United States
Sponsor
Pacific Clear Vision Institute
NCT06466525 Phase 1
Recruiting
A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability,...
Condition
Parkinson Disease
Enrollment
64 pts
Location
Australia
Sponsor
Longevity Biotech Australia Pt
NCT07264790 Phase 1
Recruiting
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous F...
Condition
Breast Reconstruction
Enrollment
25 pts
Location
United States
Sponsor
Duke University
NCT07215923 Phase 1
Recruiting
A First in Human Single Ascending Dose (SAD) Study of ATI-1013 in Healthy Smoker...
Condition
Thromboangiitis Obliterans (Buerger's Disease)
Enrollment
15 pts
Location
United States
Sponsor
Antidote Therapeutics, Inc
NCT06799026 Phase 1
Recruiting
A Phase 1 Study of Vaccination With Dendritic Cell (DC)/Multiple Myeloma (MM) Fu...
Condition
Multiple Myeloma
Enrollment
25 pts
Location
United States
Sponsor
David Avigan
NCT06750185 Phase 1
Recruiting
Safety and Preliminary Effectiveness of BNT317, an Investigational Therapy for A...
Condition
Advanced Solid Tumor
Enrollment
39 pts
Location
United States, Australia
Sponsor
BioNTech SE
NCT04615013 Phase 1
Recruiting
NBTXR3, Chemotherapy, and Radiation Therapy for the Treatment of Esophageal Canc...
Condition
Cervical Esophagus Adenocarcinoma
Enrollment
24 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT06498713 Phase 1
Recruiting
Patient Controlled Administration of Liquid Acetaminophen
Condition
Pain
Enrollment
24 pts
Location
United States
Sponsor
Yale University
NCT07161180 Phase 1
Recruiting
Evaluation of the Pharmacokinetics of "PBK_M2301" in Healthy Adults
Condition
Healthy Volunteers
Enrollment
32 pts
Location
South Korea
Sponsor
Pharmbio Korea Co., Ltd.
NCT04545762 Phase 1
Recruiting
Anti-CD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refract...
Condition
Refractory Non-Hodgkin Lymphoma
Enrollment
36 pts
Location
United States
Sponsor
C. Babis Andreadis
NCT06252220 Phase 1
Recruiting
First in Human Study in Subjects With Obesity, But Otherwise Healthy
Condition
Obesity
Enrollment
139 pts
Location
United States
Sponsor
NeuroBo Pharmaceuticals Inc.
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