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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
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
NCT07064005 Phase 1
Recruiting
Enrichment of Glutathione Using Gamma-glutamylcysteine Supplementation in Parkin...
Condition
Parkinsons Disease (PD)
Enrollment
12 pts
Location
United States
Sponsor
Pravat Mandal
NCT06048094 Phase 1
Recruiting
18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Ster...
Condition
Brain Metastases
Enrollment
46 pts
Location
United States
Sponsor
Baptist Health South Florida
NCT07334080 Phase 1
Recruiting
ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Particip...
Condition
Metabolic Dysfunction-Associated Steatohepatitis
Enrollment
72 pts
Location
Australia
Sponsor
Eccogene
NCT07050173 Phase 1
Recruiting
Monitoring Patients With Repetitive Head Impact With Gamma-glutamylcysteine Supp...
Condition
Repetitive Head Impacts
Enrollment
30 pts
Location
United States
Sponsor
Pravat Mandal
NCT07529951 Phase 1
Recruiting
Study of ZE74-0282 in Patients With JAK2 V617F- or Calreticulin-Mutated Hematolo...
Condition
Polycythemia Vera (PV)
Enrollment
60 pts
Location
Australia, Uzbekistan
Sponsor
Eilean Therapeutics
NCT05156203 Phase 1
Recruiting
Safety and Tolerability Study for T-1301 Capsules to Treat Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
30 pts
Location
Taiwan
Sponsor
Taivex Therapeutics Corporatio
NCT07038720 Phase 1
Recruiting
A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moder...
Condition
Plaque Psoriasis
Enrollment
124 pts
Location
China
Sponsor
Usynova Pharmaceuticals Ltd.
NCT06935682 Phase 1
Recruiting
Safety and Pharmacokinetics of Y-4 Tablets in Healthy Subjects
Condition
Healthy Adult Male and Female Volunteers
Enrollment
36 pts
Location
China
Sponsor
Beijing Tiantan Hospital
NCT07762287 Phase 1
Recruiting
Evaluation of Possible Ways the Body May Process Two Different Forms of Elinzane...
Condition
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women
Enrollment
100 pts
Location
Canada
Sponsor
Bayer
NCT05547321 Phase 1
Recruiting
Efficacy and Safety Study of OMTX705, Monotherapy and Anti-PD-1-combined, in Sub...
Condition
Advanced Solid Tumor
Enrollment
150 pts
Location
United States, Spain
Sponsor
Oncomatryx Biopharma S.L.
NCT06543381 Phase 1
Recruiting
Olutasidenib for the Treatment of Patients With IDH1 Mutated AML, MDS or CMML Af...
Condition
Acute Myeloid Leukemia
Enrollment
15 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT06424665 Phase 1
Recruiting
A Study of FZ-AD005 in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumor, SCLC(Small Cell Lung Cancer) or LCNEC (Large Cell Neuroendocrine Carcinoma)
Enrollment
162 pts
Location
China
Sponsor
Shanghai Fudan-Zhangjiang Bio-
NCT05318534 Phase 1
Recruiting
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male...
Condition
First in Man Study to Evaluate Initial Safety
Enrollment
70 pts
Location
United Kingdom
Sponsor
Gliknik Inc.
NCT06990698 Phase 1
Recruiting
A Phase 1 Study to Investigate FP008 in Subjects With Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
108 pts
Location
China
Sponsor
Zhuhai Fapon Biopharma Co., Lt
NCT07331272 Phase 1
Recruiting
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythe...
Condition
Systemic Lupus Erythematosus (SLE)
Enrollment
38 pts
Location
China
Sponsor
Nanjing Legend Biotech Co.
NCT07759167 Phase 1
Recruiting
Study of 3 Monoclonal Antibodies (REGN9933, REGN7508, and REGN9533) in Adult Par...
Condition
End-Stage Kidney Disease (ESKD)
Enrollment
36 pts
Location
Belgium
Sponsor
Regeneron Pharmaceuticals
NCT07750132 Phase 1
Recruiting
Phase I Study of SM2275 Injection in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
72 pts
Location
China
Sponsor
Beijing StarMab Biomed Technol
NCT06975787 Phase 1
Recruiting
Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupu...
Condition
Lupus Nephritis (LN)
Enrollment
90 pts
Location
United States, France, Germany
Sponsor
Regeneron Pharmaceuticals
NCT05225363 Phase 1
Recruiting
Modified Immune Cells (TAG72-CAR T Cells) for the Treatment of Patients With Pla...
Condition
Platinum-Resistant Ovarian Carcinoma
Enrollment
33 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT07828236 Phase 1
Recruiting
Lm-LLO-TT and Gemcitabine in Unresectable Pancreatic Ductal Adenocarcinoma
Condition
Pancreas Cancer, Duct Cell Adenocarcinoma
Enrollment
18 pts
Location
United States
Sponsor
Loki Therapeutics, Inc.
NCT07573111 Phase 1
Recruiting
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hema...
Condition
Acute Leukemia
Enrollment
12 pts
Location
United States
Sponsor
Laguna Biotherapeutics, Inc.
NCT06247787 Phase 1
Recruiting
A Study to Find the Highest Dose of Imetelstat in Combination With Fludarabine a...
Condition
Recurrent Childhood Acute Myeloid Leukemia
Enrollment
36 pts
Location
United States
Sponsor
Children's Oncology Group
NCT07264790 Phase 1
Recruiting
Assessment of Topical Minoxidil on Intraoperative Flap Perfusion and Cutaneous F...
Condition
Breast Reconstruction
Enrollment
25 pts
Location
United States
Sponsor
Duke University
NCT07778524 Phase 1
Recruiting
Alpelisib Challenge Test (ACT)
Condition
Insulin Resistance
Enrollment
15 pts
Location
United States
Sponsor
Columbia University
NCT06258408 Phase 1
Recruiting
A Phase 1 Study of BB102 in Participants With Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
78 pts
Location
China
Sponsor
Broadenbio Ltd., Co.
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