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
589
Recruiting Now
589
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
NCT05104515 Phase 1
Recruiting
First-in-human Study of OVM-200 as a Therapeutic Cancer Vaccine
Condition
Prostate Cancer
Enrollment
36 pts
Location
United Kingdom
Sponsor
Oxford Vacmedix UK Ltd.
NCT06448013 Phase 1
Recruiting
A Phase I Study Investigating the Combination of the Menin Inhibitor Ziftomenib ...
Condition
Acute Myeloid Leukemia
Enrollment
22 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT05757310 Phase 1
Recruiting
A Reduced-Intensity Conditioning Regimen (Cyclophosphamide, Pentostatin, Anti-th...
Condition
Recurrent Severe Aplastic Anemia
Enrollment
6 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT07349758 Phase 1
Recruiting
Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
Condition
Healthy Volunteer
Enrollment
24 pts
Location
United States
Sponsor
Johns Hopkins University
NCT07543055 Phase 1
Recruiting
A Phase 1 Study of BPX-601 CAR T-Cell Therapy in Adult Participants With Prostat...
Condition
Prostate Cancer
Enrollment
36 pts
Location
United States
Sponsor
Regeneron Pharmaceuticals
NCT07570017 Phase 1
Recruiting
A Study of Rocbrutinib Combined With R-GemOx in Patients With Relapsed or Refrac...
Condition
DLBCL
Enrollment
42 pts
Location
China
Sponsor
Guangzhou Lupeng Pharmaceutica
NCT07547540 Phase 1
Recruiting
A Study of LY3971297 in Participants With Heart Failure
Condition
Heart Failure
Enrollment
90 pts
Location
United States, Japan, Moldova
Sponsor
Eli Lilly and Company
NCT07662148 Phase 1
Recruiting
A Study to Learn More About the Safety of a Single Dose of BIIB144 and How it is...
Condition
Healthy Volunteer
Enrollment
48 pts
Location
United States
Sponsor
Biogen
NCT06060782 Phase 1
Recruiting
Thiotepa, Cyclophosphamide, Clarithromycin and Cytarabine
Condition
Burkitt Lymphoma
Enrollment
28 pts
Location
China
Sponsor
Fifth Affiliated Hospital, Sun
NCT07016997 Phase 1
Recruiting
A Phase I, First in Human Study of CBA-1535, T Cell Engager(5T4/CD3/5T4) in Pati...
Condition
Solid Tumors
Enrollment
70 pts
Location
Japan
Sponsor
Chiome Bioscience Inc.
NCT07150026 Phase 1
Recruiting
An Exploratory Evaluation of the Safety and Efficacy of Vorinostat in Pitt Hopki...
Condition
Pitt Hopkins Syndrome
Enrollment
5 pts
Location
Colombia
Sponsor
Unravel Biosciences, Inc.
NCT07645235 Phase 1
Recruiting
A Study to Evaluate Gepotidacin Exposure in Breast Milk of Healthy Lactating Wom...
Condition
Urinary Tract Infections
Enrollment
8 pts
Location
United States
Sponsor
GlaxoSmithKline
NCT05001750 Phase 1
Recruiting
Prophylactic Antibiotics Useful With Antibiotic Impregnated External Ventricular...
Condition
Subarachnoid Hemorrhage
Enrollment
84 pts
Location
United States
Sponsor
Montefiore Medical Center
NCT04443088 Phase 1
Recruiting
An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembro...
Condition
Cancer
Enrollment
78 pts
Location
United States
Sponsor
Shenzhen Ionova Life Sciences
NCT07110883 Phase 1
Recruiting
A Clinical Study of SYS6023 in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
400 pts
Location
China
Sponsor
CSPC Megalith Biopharmaceutica
NCT05121779 Phase 1
Recruiting
Head-to-head Comparison of Diagnosis Value of Pulmonary Fibrosis on 68Ga-FAPI-04...
Condition
Pulmonary Fibrosis
Enrollment
80 pts
Location
China
Sponsor
Peking Union Medical College H
NCT07413341 Phase 1
Recruiting
A Clinical Study of TI-0032-III Injection in Patients With Relapsed and Refracto...
Condition
Systemic Lupus Erythematosus (SLE)
Enrollment
12 pts
Location
China
Sponsor
Therorna
NCT07562841 Phase 1
Recruiting
Au-TMP and Radiotherapy for Advanced Melanoma With Anti-PD-1 Therapy
Condition
Advanced Melanoma
Enrollment
6 pts
Location
China
Sponsor
West China Hospital
NCT06307054 Phase 1
Recruiting
CLL-1 CAR-NK Cells for Relapsed/Refractory AML
Condition
Relapsed Adult AML
Enrollment
24 pts
Location
China
Sponsor
Shanghai General Hospital, Sha
NCT07087262 Phase 1
Recruiting
A Phase I Study of SNH-119014 in Healthy Volunteers
Condition
Hemoglobinopathy
Enrollment
96 pts
Location
China
Sponsor
ScinnoHub Pharmaceutical Co.,
NCT07250269 Phase 1
Recruiting
Study of GC012F, CAR-T Therapy Targeting CD19 and BCMA in Chinese Participants W...
Condition
Relapsed/Refractory AL Amyloidosis
Enrollment
12 pts
Location
China
Sponsor
Gracell Biotechnologies (Shang
NCT07645651 Phase 1
Recruiting
Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectabl...
Condition
Resectable Pancreatic Ductal Adenocarcinoma
Enrollment
15 pts
Location
United States
Sponsor
University of Washington
NCT06713369 Phase 1
Recruiting
AZD5305 hADME in Patients With Advanced Solid Malignancies
Condition
Locally Advanced or Metastatic Solid Tumor
Enrollment
8 pts
Location
United Kingdom
Sponsor
AstraZeneca
NCT07853131 Phase 1
Recruiting
Study to Assess the Plasma Concentration of Rilzabrutinib Given as a Tablet to A...
Condition
Renal Impairment
Enrollment
16 pts
Location
United States
Sponsor
Sanofi
NCT07035769 Phase 1
Recruiting
A First-in-Human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of...
Condition
Healthy Participants
Enrollment
112 pts
Location
Belgium
Sponsor
Debiopharm International SA
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