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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
NCT05155189 Phase 1
Recruiting
A Study to Evaluate Safety and Efficacy of Armored CAR-T Cell Injection C-CAR031...
Condition
Hepatocellular Carcinoma
Enrollment
72 pts
Location
China
Sponsor
Zhejiang University
NCT07498218 Phase 1
Recruiting
Phase 1 Study of VELGRAFT, a Living Cellular Construct, in the Management of Chr...
Condition
Diabetic Foot Ulcer (DFU)
Enrollment
24 pts
Location
United States
Sponsor
Ayu, Inc.
NCT04806347 Phase 1
Recruiting
Alpha/Beta T-cell Depleted Blood-forming Stem Cell Transplant From Related or Un...
Condition
Blood Disease
Enrollment
12 pts
Location
United States
Sponsor
University of Wisconsin, Madis
NCT03922555 Phase 1
Recruiting
ASTX727 in Recurrent/Progressive Non-enhancing IDH Mutant Gliomas
Condition
Neurological Cancer
Enrollment
18 pts
Location
United States
Sponsor
Massachusetts General Hospital
NCT06867497 Phase 1
Recruiting
A Study to Compare and Evaluate the Pharmacokinetic Characteristics and the Safe...
Condition
Metastatic Adenocarcinoma of the Pancreas
Enrollment
20 pts
Location
South Korea
Sponsor
Boryung Pharmaceutical Co., Lt
NCT06305910 Phase 1
Recruiting
CD200AR-L and Allogeneic Tumor Lysate Vaccine Immunotherapy for Recurrent HGG an...
Condition
Diffuse Midline Glioma, H3 K27M-Mutant
Enrollment
24 pts
Location
United States
Sponsor
OX2 Therapeutics
NCT03705715 Phase 1
Recruiting
Identifying Correlates of Brain Microglial Activation in Neuropsychiatric Syndro...
Condition
Neuropsychiatric Syndromes
Enrollment
200 pts
Location
United States
Sponsor
The University of Texas Health
NCT07047989 Phase 1
Recruiting
NWRD09 for HPV-16 Related Cervical HSIL
Condition
High-grade Squamous Intraepithelial Lesion (HSIL)
Enrollment
9 pts
Location
China
Sponsor
Newish Biotech (Wuxi) Co., Ltd
NCT07201558 Phase 1
Recruiting
Study Evaluating Safety, Tolerability, PK/PD of Surovatamig in Adult RA or SLE P...
Condition
Rheumatoid Arthritis
Enrollment
48 pts
Location
United States, Australia, Belgium
Sponsor
AstraZeneca
NCT07368478 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Prelimi...
Condition
Advanced Solid Malignancies
Enrollment
180 pts
Location
China
Sponsor
Biocity Biopharmaceutics Co.,
NCT07532525 Phase 1
Recruiting
Pomalidomide After CAR T-cell Therapy for the Treatment of Relapsed or Refractor...
Condition
Recurrent B Acute Lymphoblastic Leukemia
Enrollment
12 pts
Location
United States
Sponsor
University of Michigan Rogel C
NCT04975152 Phase 1
Recruiting
Neoadjuvant Cemiplimab in Newly Diagnosed or Recurrent Stage I-II Merkel Cell Ca...
Condition
Merkel Cell Carcinoma
Enrollment
36 pts
Location
United States
Sponsor
H. Lee Moffitt Cancer Center a
NCT07886047 Phase 1
Recruiting
Propranolol Hydrochloride Combined With Adebrelimab and Platinum-Based Chemother...
Condition
Small Cell Lung Cancer (SCLC)
Enrollment
18 pts
Location
China
Sponsor
Second Xiangya Hospital of Cen
NCT07014449 Phase 1
Recruiting
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
Condition
AML (Acute Myelogenous Leukemia
Enrollment
36 pts
Location
China
Sponsor
Hangzhou Weben Pharma Co., Ltd
NCT07730190 Phase 1
Recruiting
A Clinical Trial of TQB6426 for Injection in Patients With Advanced Solid Tumors
Condition
Advanced Malignancies
Enrollment
145 pts
Location
China
Sponsor
Shanghai Chia Tai Tianqing Pha
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
NCT07182149 Phase 1
Recruiting
A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic R...
Condition
HNSCC
Enrollment
150 pts
Location
United States
Sponsor
Normunity AccelCo, Inc.
NCT06297525 Phase 1
Recruiting
Study of STP938 (Dencatistat) in Advanced Solid Tumours
Condition
Solid Tumor
Enrollment
70 pts
Location
United States, France, United Kingdom
Sponsor
Step Pharma, SAS
NCT05725291 Phase 1
Recruiting
AMT-116 in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
80 pts
Location
United States, American Samoa, Australia
Sponsor
Multitude Therapeutics Inc.
NCT06414096 Phase 1
Recruiting
Use of Pulsatile Intravenous FSH to Mitigate Reprometabolic Syndrome
Condition
Infertility
Enrollment
60 pts
Location
United States
Sponsor
University of Colorado, Denver
NCT06198296 Phase 1
Recruiting
Immunotherapy For Adults With GPC3-Positive Solid Tumors Using IL-15 and IL-21 A...
Condition
Hepatoblastoma
Enrollment
21 pts
Location
United States
Sponsor
Baylor College of Medicine
NCT07874503 Phase 1
Recruiting
Safety and Efficacy of Cultivated Allogeneic Corneal Endothelial Cells Attached ...
Condition
Corneal Endothelial Cell Dysfunction
Enrollment
30 pts
Location
El Salvador
Sponsor
OcuCell
NCT06687070 Phase 1
Recruiting
APG-2449 Monotherapy or in Combination With PLD in Patients With Platinum-resist...
Condition
Platinum-resistant Recurrent Ovarian Cancer
Enrollment
90 pts
Location
China
Sponsor
Ascentage Pharma Group Inc.
NCT05815173 Phase 1
Recruiting
Ladarixin With Sotorasib in Advanced NSCLC
Condition
Advanced Non-small Cell Lung Cancer With KRAS G12C Mutation
Enrollment
40 pts
Location
United States
Sponsor
NYU Langone Health
NCT06966388 Phase 1
Recruiting
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in ...
Condition
Breast Cancer
Enrollment
33 pts
Location
United States
Sponsor
Virginia Commonwealth Universi
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