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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
575
Recruiting Now
575
Top Conditions in Phase 1
Advanced Solid Tumor (19) Acute Myeloid Leukemia (19) Solid Tumor (19) Healthy (16) Breast Cancer (15) Advanced Solid Tumors (15) Ovarian Cancer (13) Healthy Volunteers (11) Endometrial Cancer (10) Colorectal Cancer (9)

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

NCT06146257 Phase 1
Recruiting
A Study of GLB-001 in Patients With Relapsed or Refractory Acute Myeloid Leukemi...
Condition
Acute Myeloid Leukemia
Enrollment
48 pts
Location
United States
Sponsor
GluBio Therapeutics Inc.
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NCT05859074 Phase 1
Recruiting
A Study of MQ710 With and Without Pembrolizumab in People With Solid Tumor Cance...
Condition
Cutaneous Squamous Cell Carcinoma
Enrollment
56 pts
Location
United States
Sponsor
Memorial Sloan Kettering Cance
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NCT07579182 Phase 1
Recruiting
Hormones, Outcomes, and Pain Pathways in Exercise Study
Condition
Breast Pain
Enrollment
140 pts
Location
United States
Sponsor
University of Houston
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NCT06980428 Phase 1
Recruiting
A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynam...
Condition
Healthy Participants
Enrollment
136 pts
Location
United States
Sponsor
AstraZeneca
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NCT04934228 Phase 1
Recruiting
Mitigating the Pro-inflammatory Phenotype of Obesity
Condition
Blood Pressure
Enrollment
60 pts
Location
United States
Sponsor
University of Kansas Medical C
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NCT06823609 Phase 1
Recruiting
Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Ma...
Condition
Advanced Malignant Tumor
Enrollment
180 pts
Location
China
Sponsor
Qilu Pharmaceutical Co., Ltd.
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NCT07280936 Phase 1
Recruiting
A Study of SHR-2906 Injection in Healthy Subjects With a Single Dose and in Obes...
Condition
Obesity
Enrollment
124 pts
Location
China
Sponsor
Beijing Suncadia Pharmaceutica
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NCT06576271 Phase 1
Recruiting
A Study of GSK4527363 in Healthy Participants, Systemic Lupus Erythematosus (SLE...
Condition
Systemic Lupus Erythematosus
Enrollment
142 pts
Location
United States, Argentina, Brazil
Sponsor
GlaxoSmithKline
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NCT07338487 Phase 1
Recruiting
A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradioth...
Condition
Locally Advanced Cervical Cancer
Enrollment
88 pts
Location
China
Sponsor
Second Xiangya Hospital of Cen
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NCT06469281 Phase 1
Recruiting
A Study to Learn if 27T51, a Mucin-16 (MUC16) Protein Targeting Immune Cell Ther...
Condition
Epithelial Ovarian Cancer
Enrollment
90 pts
Location
United States
Sponsor
Regeneron Pharmaceuticals
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NCT07371468 Phase 1
Recruiting
A Study of GSK5926371 in Participants With B-cell Driven Autoimmune Rheumatic Di...
Condition
Systemic Lupus Erythematosus
Enrollment
44 pts
Location
Argentina, Brazil, France
Sponsor
GlaxoSmithKline
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NCT06832189 Phase 1
Recruiting
EVR and EPO for Liver Transplant Tolerance
Condition
Liver Transplant
Enrollment
20 pts
Location
United States
Sponsor
National Institute of Allergy
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NCT07124468 Phase 1
Recruiting
Assess the Plasma, Epithelial Lining, and Alveolar Macrophage Concentrations of ...
Condition
Infections
Enrollment
16 pts
Location
China
Sponsor
Qilu Pharmaceutical Co., Ltd.
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NCT07794150 Phase 1
Recruiting
A Study to Assess the Skin Irritation and Sensitization of Estradiol/Levonorgest...
Condition
Menopause
Enrollment
250 pts
Location
United States, India
Sponsor
Corium Innovations, Inc.
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NCT06576037 Phase 1
Recruiting
Phase Ib Study of CBP-1019 in Combination With FOLFOX +/- Bevacizumab, Pembroliz...
Condition
Solid Tumor
Enrollment
128 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT07422675 Phase 1
Recruiting
SAD Study in Patients With Parkinson's Disease and Motor Fluctuations
Condition
PARKINSON DISEASE (Disorder)
Enrollment
40 pts
Location
United States, Australia
Sponsor
Serina Therapeutics
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NCT07236801 Phase 1
Recruiting
Exploratory Clinical Study on YTS109 Cell Therapy for Autoimmune Diseases
Condition
Systemic Lupus Erythematosus (SLE)
Enrollment
18 pts
Location
China
Sponsor
China Immunotech (Beijing) Bio
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NCT07282171 Phase 1
Recruiting
A Study to Investigate the Safety, Pharmacodynamic and Pharmacokinetic Character...
Condition
sFlt1 Mediated Preterm Preeclampsia
Enrollment
60 pts
Location
Australia
Sponsor
Comanche Biopharma
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NCT06186401 Phase 1
Recruiting
Anti-EGFRvIII synNotch Receptor Induced Anti-EphA2/IL-13Ralpha2 CAR (E-SYNC) T C...
Condition
EGFR Gene Mutation
Enrollment
20 pts
Location
United States
Sponsor
Hideho Okada, MD, PhD
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NCT06469008 Phase 1
Recruiting
A Study of BL-B16D1 in Patients With Recurrent or Metastatic Head and Neck Squam...
Condition
Head and Neck Squamous Cell Carcinomas
Enrollment
21 pts
Location
China
Sponsor
Sichuan Baili Pharmaceutical C
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NCT07225816 Phase 1
Recruiting
Examination of How the Duration of Fasting and Temporary Stopping of GLP-1 Medic...
Condition
Obesity
Enrollment
71 pts
Location
United States
Sponsor
Novo Nordisk A/S
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NCT07455617 Phase 1
Recruiting
Study of ABO2102 in KRAS-Mutated Solid Tumors
Condition
Advanced / Metastatic Solid Tumor
Enrollment
101 pts
Location
China
Sponsor
Suzhou Abogen Biosciences Co.,
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NCT05664113 Phase 1
Recruiting
Feasibility, Safety, and Potential Efficacy of Fecal Microbiota Transplantation ...
Condition
Gastro-Intestinal Disorder
Enrollment
10 pts
Location
United States
Sponsor
St. Jude Children's Research H
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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
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NCT02508038 Phase 1
Recruiting
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric ...
Condition
Acute Myeloid Leukemia
Enrollment
22 pts
Location
United States
Sponsor
University of Wisconsin, Madis
View Trial →
Page 3 of 23 — 575 trials total
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