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
569
Recruiting Now
569
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
NCT06641609 Phase 1
Recruiting
A Phase I Study of CFT8919 in Patients With Advanced NSCLC
Condition
Non-Small Cell Lung Cancer With EGFR Mutation
Enrollment
166 pts
Location
China
Sponsor
Betta Pharmaceuticals Co., Ltd
NCT05204147 Phase 1
Recruiting
Actinium 225 Labeled Anti-CEA Antibody (Ac225-DOTA-M5A) for the Treatment of CEA...
Condition
Advanced Cancer
Enrollment
20 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT05819892 Phase 1
Recruiting
Phase I Trial Testing the Safety and Tolerability of Chemoradiation Followed by ...
Condition
Endometrial Cancer
Enrollment
21 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT07144111 Phase 1
Recruiting
A Study to Evaluate the Effect of Moderate or Severe Hepatic Impairment on the P...
Condition
Hepatic Impairment
Enrollment
32 pts
Location
United States
Sponsor
Genentech, Inc.
NCT04521764 Phase 1
Recruiting
A Vaccine (MV-s-NAP) for the Treatment of Patients With Invasive Metastatic Brea...
Condition
Anatomic Stage IV Breast Cancer AJCC v8
Enrollment
54 pts
Location
United States
Sponsor
Mayo Clinic
NCT07118085 Phase 1
Recruiting
A Randomized, Double-blind, Placebo-controlled, Single and Multiple Dose Escalat...
Condition
Healthy Postmenopausal Women
Enrollment
56 pts
Location
China
Sponsor
ImmuneOnco Biopharmaceuticals
NCT02897700 Phase 1
Recruiting
A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal...
Condition
Breast Cancer
Enrollment
300 pts
Location
China
Sponsor
Shanghai Jiao Tong University
NCT07725809 Phase 1
Recruiting
A Study to Learn How the Study Medicine Called PF-08653945 is Taken up Into the ...
Condition
Overweight
Enrollment
57 pts
Location
Belgium
Sponsor
Pfizer
NCT06945614 Phase 1
Recruiting
Exploratory Clinical Study to Assess Safety and Efficacy of Xenon Gas Inhalation...
Condition
Healthy Volunteer Study
Enrollment
16 pts
Location
United States
Sponsor
General Biophysics LLC
NCT04716452 Phase 1
Recruiting
Study of C6 Ceramide NanoLiposome (CNL) in Patients With Relapsed/Refractory Acu...
Condition
Acute Myeloid Leukemia, in Relapse
Enrollment
15 pts
Location
United States
Sponsor
Keystone Nano, Inc
NCT02254863 Phase 1
Recruiting
UCB Transplant of Inherited Metabolic Diseases With Administration of Intratheca...
Condition
Adrenoleukodystrophy
Enrollment
40 pts
Location
United States
Sponsor
Joanne Kurtzberg, MD
NCT06519552 Phase 1
Recruiting
A Clinical Study Evaluating the Safety, Tolerability, and Initial Efficacy of JW...
Condition
Mucopolysaccharidosis Type I
Enrollment
6 pts
Location
China
Sponsor
West China Hospital
NCT06977711 Phase 1
Recruiting
Loncastuximab and Roflumilast Added to R-CHOP (Lo-(Rituximab and Roflumilast) RR...
Condition
Diffuse Large B-cell Lymphoma
Enrollment
10 pts
Location
United States
Sponsor
The University of Texas Health
NCT07691606 Phase 1
Recruiting
A Study of ARC-02 in B-cell NHL
Condition
B-cell Non Hodgkin Lymphoma
Enrollment
140 pts
Location
United States, Australia, France
Sponsor
Taiho Oncology, Inc.
NCT06630884 Phase 1
Recruiting
Inflammatory Challenge and Fear
Condition
Posttraumatic Stress Disorder (PTSD)
Enrollment
288 pts
Location
United States
Sponsor
University of California, San
NCT07366658 Phase 1
Recruiting
Safety, Tolerability and Preliminary Efficacy of NEUK203-13 in Refractory Neuroe...
Condition
SCLC, Extensive Stage
Enrollment
9 pts
Location
China
Sponsor
Cancer Institute and Hospital,
NCT05610878 Phase 1
Recruiting
Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting
Condition
Romberg Disease
Enrollment
24 pts
Location
Pakistan
Sponsor
University of the Punjab
NCT06136364 Phase 1
Recruiting
CD7 CAR-T in Adults With Relapsed or Refractory T-LBL/ALL Clinical Study
Condition
T-lymphoblastic Lymphoma
Enrollment
9 pts
Location
China
Sponsor
Hebei Senlang Biotechnology In
NCT06815432 Phase 1
Recruiting
GPC-3 CAR T CELLS FOR Recurrent GPC-3 Positive Glioblastoma
Condition
Glioblastoma Multiforme of Brain
Enrollment
27 pts
Location
United States
Sponsor
Baylor College of Medicine
NCT05857332 Phase 1
Recruiting
SG1906 for CLDN18.2-Positive Solid Tumors
Condition
Locally Advanced Unresectable or Metastatic Solid Tumors
Enrollment
60 pts
Location
China
Sponsor
Hangzhou Sumgen Biotech Co., L
NCT06410092 Phase 1
Recruiting
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL...
Condition
Solid Tumor
Enrollment
44 pts
Location
China
Sponsor
Sound Biopharmaceuticals Ltd.
NCT07643155 Phase 1
Recruiting
A Study to Evaluate the Pharmacokinetics (PK) and Safety of a Single Dose of Tre...
Condition
Hepatic Impairment
Enrollment
30 pts
Location
United States
Sponsor
Insmed Incorporated
NCT05967299 Phase 1
Recruiting
Study of Intravenous ZMA001 in Healthy Subjects
Condition
Pulmonary Arterial Hypertension PAH
Enrollment
96 pts
Location
United States
Sponsor
National Heart, Lung, and Bloo
NCT05187832 Phase 1
Recruiting
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic...
Condition
Advanced or Metastatic Breast Cancer
Enrollment
61 pts
Location
United States
Sponsor
Kind Pharmaceuticals LLC
NCT05306132 Phase 1
Recruiting
Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-...
Condition
Advanced Solid Tumor
Enrollment
150 pts
Location
China
Sponsor
Jiangsu Aosaikang Pharmaceutic
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