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
584
Recruiting Now
584
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
NCT04691622 Phase 1
Recruiting
Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunoco...
Condition
Viral Infection
Enrollment
48 pts
Location
United States
Sponsor
Children's National Research I
NCT06995651 Phase 1
Recruiting
Dorzagliatin in Pancreatic Insufficient Cystic Fibrosis
Condition
Pancreatic Insufficiency
Enrollment
15 pts
Location
United States
Sponsor
Michael R. Rickels, MD, MS
NCT05172245 Phase 1
Recruiting
Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head...
Condition
Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8
Enrollment
46 pts
Location
United States, Canada
Sponsor
National Cancer Institute (NCI
NCT07281326 Phase 1
Recruiting
A Study of AK138D1 in Advanced Malignant Tumors
Condition
Solid Cancer
Enrollment
200 pts
Location
China
Sponsor
Akeso
NCT06718621 Phase 1
Recruiting
A Study of BL-M08D1 in Patients With Locally Advanced or Metastatic Solid Tumors
Condition
Solid Tumor
Enrollment
22 pts
Location
China
Sponsor
Sichuan Baili Pharmaceutical C
NCT06843317 Phase 1
Recruiting
Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adult...
Condition
RSV Infection
Enrollment
160 pts
Location
United States
Sponsor
Clover Biopharmaceuticals USA,
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
NCT07020117 Phase 1
Recruiting
A Study of [225Ac]Ac-AKY-1189 in Patients With Solid Tumors
Condition
Urothelial Carcinoma Bladder
Enrollment
150 pts
Location
United States
Sponsor
Aktis Oncology, Inc.
NCT06393738 Phase 1
Recruiting
A Study of ARV-393 in Relapsed/Refractory Non-Hodgkin Lymphoma.
Condition
Relapsed/Refractory (R/R) Mature B Cell Non Hodgkin Lymphoma (NHL)
Enrollment
329 pts
Location
United States, Australia, Canada
Sponsor
Arvinas Inc.
NCT04187443 Phase 1
Recruiting
MS-553 in Diabetic Retinopathy Patients With Central Involved Macular Edema
Condition
Diabetic Macular Edema
Enrollment
45 pts
Location
China
Sponsor
Shenzhen MingSight Relin Pharm
NCT07861035 Phase 1
Recruiting
A Phase I Study of Allogeneic Myocardium-Derived Mesenchymal Stem Cells (HB1011)...
Condition
Ischemic Cardiomyopathy
Enrollment
12 pts
Location
South Korea
Sponsor
HieraBio Inc.
NCT07128914 Phase 1
Recruiting
A Clinical Study of GO306 in Patients With Advanced Solid Tumors
Condition
Solid Tumor Malignancies
Enrollment
32 pts
Location
China
Sponsor
GeneSail Biotech (Shanghai) Co
NCT07757152 Phase 1
Recruiting
Phase I Clinical Study of ZL-65 Tablet in Healthy Adult Participants in China
Condition
Healthy Participants Study
Enrollment
108 pts
Location
China
Sponsor
Chengdu Zenitar Biomedical Tec
NCT06349408 Phase 1
Recruiting
IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid ...
Condition
Locally Advanced Solid Tumor
Enrollment
250 pts
Location
United States, Australia, China
Sponsor
Fortvita Biologics (USA)Inc.
NCT07053306 Phase 1
Recruiting
SGLT2i, Ketoacidosis, Volume Contraction, and Insulinopenia
Condition
Type 2 Diabetes
Enrollment
29 pts
Location
United States
Sponsor
The University of Texas Health
NCT07379125 Phase 1
Recruiting
Therapeutic RSK1 Targeting in Myeloid Malignancies
Condition
Myeloid Malignancy
Enrollment
30 pts
Location
United States
Sponsor
Washington University School o
NCT07688252 Phase 1
Recruiting
Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma
Condition
High Risk Neuroblastoma
Enrollment
30 pts
Location
Taiwan
Sponsor
Chang Gung Memorial Hospital
NCT06889168 Phase 1
Recruiting
Evaluating the Long-term Safety and Tolerability of Imatinib in Patients With Ly...
Condition
Lymphangioleiomyomatosis (LAM)
Enrollment
20 pts
Location
United States
Sponsor
Columbia University
NCT06173518 Phase 1
Recruiting
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed ...
Condition
Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Enrollment
30 pts
Location
United States, Spain, United Kingdom
Sponsor
Autolus Limited
NCT05470348 Phase 1
Recruiting
A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic...
Condition
Breast Cancer
Enrollment
36 pts
Location
China
Sponsor
Sichuan Baili Pharmaceutical C
NCT07764146 Phase 1
Recruiting
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheim...
Condition
Alzheimer s Disease
Enrollment
18 pts
Location
United States
Sponsor
Voyager Therapeutics
NCT06702488 Phase 1
Recruiting
Dexmedetomidine and Magnesium Sulfate in the Reduction Cognitive Dysfunction in ...
Condition
Mental Disorder
Enrollment
58 pts
Location
Egypt
Sponsor
Fayoum University
NCT07284797 Phase 1
Recruiting
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Partic...
Condition
Healthy
Enrollment
60 pts
Location
Australia
Sponsor
Xencor, Inc.
NCT07318259 Phase 1
Recruiting
Study of Ultra-Fast BCMA/CD70 CAR-T Therapy for Refractory SLE
Condition
Systemic Lupus Erythematosus
Enrollment
18 pts
Location
China
Sponsor
Chongqing Precision Biotech Co
NCT07797985 Phase 1
Recruiting
To Identify if a COPD Self-management App Can Safety and Appropriately Identify ...
Condition
Respiration Disorders
Enrollment
746 pts
Location
United Kingdom
Sponsor
University of Southampton
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