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
NCT05143996 Phase 1
Recruiting
CLN-049 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (AML) or Mye...
Condition
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Enrollment
60 pts
Location
United States
Sponsor
Cullinan Therapeutics Inc.
NCT06770569 Phase 1
Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of H...
Condition
Advanced Solid Tumors
Enrollment
100 pts
Location
Australia, China
Sponsor
Shandong Suncadia Medicine Co.
NCT06343805 Phase 1
Recruiting
A Phase 1 Study of AJ1-11095 in Patients With Primary Myelofibrosis (PMF), Post-...
Condition
Primary Myelofibrosis
Enrollment
76 pts
Location
United States, France, Italy
Sponsor
Ajax Therapeutics, Inc.
NCT05244551 Phase 1
Recruiting
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK061 in Patie...
Condition
Solid Tumor
Enrollment
85 pts
Location
United States, China
Sponsor
Abbisko Therapeutics Co, Ltd
NCT06636227 Phase 1
Recruiting
Diclofenac Dose Response Study
Condition
Alcohol Use Disorder (AUD)
Enrollment
24 pts
Location
United States
Sponsor
University of Maryland, Baltim
NCT07171983 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in P...
Condition
Rheumatoid Arthritis
Enrollment
46 pts
Location
India
Sponsor
Bristol-Myers Squibb
NCT07451054 Phase 1
Recruiting
CD45BE-HSPC + CART-45 Cells
Condition
B-Cell Non-Hodgkin Lymphoma (NHL)
Enrollment
42 pts
Location
United States
Sponsor
University of Pennsylvania
NCT07425522 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokine...
Condition
Diabetic Macular Edema
Enrollment
93 pts
Location
United States
Sponsor
Genentech, Inc.
NCT03294954 Phase 1
Recruiting
GD2 Specific CAR and Interleukin-15 Expressing Autologous NKT Cells to Treat Chi...
Condition
Neuroblastoma
Enrollment
70 pts
Location
United States
Sponsor
Baylor College of Medicine
NCT07064122 Phase 1
Recruiting
A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Part...
Condition
Haematologic Neoplasms
Enrollment
72 pts
Location
United States, Australia, Japan
Sponsor
AstraZeneca
NCT06487559 Phase 1
Recruiting
A Study to Assess the Adverse Events and How Intravenously Infused Livmoniplimab...
Condition
Hepatocellular Carcinoma (HCC)
Enrollment
20 pts
Location
China
Sponsor
AbbVie
NCT06347770 Phase 1
Recruiting
The Effect of Oral Gan Shuangbi During the Perinatal Period on the Recovery of I...
Condition
Microbiota
Enrollment
404 pts
Location
China
Sponsor
Zhe Li
NCT06962254 Phase 1
Recruiting
Imatinib and Trametinib for KRAS-mutated Solid Tumor
Condition
Solid Tumor Cancer
Enrollment
10 pts
Location
Taiwan
Sponsor
China Medical University Hospi
NCT05032105 Phase 1
Recruiting
The Impact of Focused Ultrasound Thalamotomy of the Anterior Nucleus for Focal-O...
Condition
Anxiety
Enrollment
10 pts
Location
United States
Sponsor
Ohio State University
NCT05915013 Phase 1
Recruiting
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components o...
Condition
Depressive Disorder, Major
Enrollment
50 pts
Location
United States
Sponsor
Yale University
NCT06179069 Phase 1
Recruiting
A Study of ZL-1310 in Subjects With Small Cell Lung Cancer
Condition
SCLC
Enrollment
339 pts
Location
United States, China, Spain
Sponsor
Zai Lab (Shanghai) Co., Ltd.
NCT07604324 Phase 1
Recruiting
A First-in-human Study to Investigate Single Doses of DCY636 in Healthy Voluntee...
Condition
Dermatitis, Atopic
Enrollment
63 pts
Location
Japan
Sponsor
Novartis Pharmaceuticals
NCT06771479 Phase 1
Recruiting
A Study Evaluating the Safety and Immunogenicity of MVA Strain Monkeypox Attenua...
Condition
Monkeypox
Enrollment
120 pts
Location
China
Sponsor
Shanghai Institute Of Biologic
NCT07281703 Phase 1
Recruiting
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY8931 in Healthy...
Condition
Healthy
Enrollment
60 pts
Location
Australia
Sponsor
Newsoara Biopharma Co., Ltd.
NCT05870423 Phase 1
Recruiting
Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors
Condition
Neuroendocrine Tumors
Enrollment
24 pts
Location
Netherlands
Sponsor
Erasmus Medical Center
NCT04972942 Phase 1
Recruiting
Targeted Immunotherapy After Myeloablative TBI-Based Conditioning & AlloHCT in C...
Condition
T-cell Acute Lymphoblastic Leukemia
Enrollment
30 pts
Location
United States
Sponsor
New York Medical College
NCT06835569 Phase 1
Recruiting
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tum...
Condition
Cancer
Enrollment
448 pts
Location
United States
Sponsor
Alterome Therapeutics, Inc.
NCT06632574 Phase 1
Recruiting
A Clinical Study of Paclitaxel Cationic Liposomes for the Treatment of Patients ...
Condition
Advanced Solid Tumor
Enrollment
60 pts
Location
China
Sponsor
CSPC ZhongQi Pharmaceutical Te
NCT02203903 Phase 1
Recruiting
Multi-institutional Prospective Research of Expanded Multi-antigen Specifically ...
Condition
Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS
Enrollment
50 pts
Location
United States
Sponsor
Catherine Bollard
NCT05304962 Phase 1
Recruiting
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Nega...
Condition
Breast Cancer
Enrollment
64 pts
Location
United States
Sponsor
Regor Pharmaceuticals Inc.
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