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
575
Recruiting Now
575
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
NCT03383978 Phase 1
Recruiting
Intracranial Injection of NK-92/5.28.z Cells in Combination With Intravenous Eza...
Condition
Glioblastoma
Enrollment
42 pts
Location
Germany
Sponsor
Johann Wolfgang Goethe Univers
NCT07333261 Phase 1
Recruiting
Study of BMS-986453 in Newly Diagnosed Multiple Myeloma
Condition
Multiple Myeloma
Enrollment
25 pts
Location
United States
Sponsor
Susan Bal
NCT07200102 Phase 1
Recruiting
Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma
Condition
Multiple Myeloma
Enrollment
20 pts
Location
United States
Sponsor
Washington University School o
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.
NCT06700395 Phase 1
Recruiting
A Clinical Study of TQB2029 for Injection in Subjects With Multiple Myeloma
Condition
Multiple Myeloma
Enrollment
136 pts
Location
China
Sponsor
Chia Tai Tianqing Pharmaceutic
NCT06241456 Phase 1
Recruiting
FT825/ONO-8250, an Off-the-Shelf, HER2 CAR-T, With or Without Monoclonal Antibod...
Condition
Advanced Solid Tumor
Enrollment
351 pts
Location
United States
Sponsor
Fate Therapeutics
NCT07152288 Phase 1
Recruiting
Investigation of Pharmacokinetics,Safety,and Pharmacodynamics of HSK39297 in Sub...
Condition
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Enrollment
24 pts
Location
China
Sponsor
Haisco Pharmaceutical Group Co
NCT05861895 Phase 1
Recruiting
HF158K1 in Patients With HER-2 Expressing Advanced Solid Tumors
Condition
Solid Tumors, Adult
Enrollment
84 pts
Location
United States, China
Sponsor
HighField Biopharmaceuticals C
NCT06006273 Phase 1
Recruiting
A Phase Ib Trial of Eribulin in Combination With Irinotecan and Temozolamide in ...
Condition
Refractory Solid Tumors
Enrollment
48 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT06087341 Phase 1
Recruiting
A Phase I Trial of Memory T Cells Expressing an NKG2D Chimeric Antigen Receptor ...
Condition
Advanced Sarcoma
Enrollment
18 pts
Location
Spain
Sponsor
Antonio Pérez Martínez
NCT05103683 Phase 1
Recruiting
First in Human Study of TORL-1-23 in Participants With Advanced Cancer
Condition
Advanced Solid Tumor
Enrollment
90 pts
Location
United States, South Korea
Sponsor
TORL Biotherapeutics, LLC
NCT07374029 Phase 1
Recruiting
Adoptive T Cell Therapy With DC/AML Fusion Vaccine Plus Decitabine and Venetocla...
Condition
Acute Myeloid Leukemia
Enrollment
30 pts
Location
United States
Sponsor
David Avigan
NCT07439796 Phase 1
Recruiting
A Study of ORN252 in Healthy Participants
Condition
Healthy Volunteers - Male and Female
Enrollment
20 pts
Location
Australia
Sponsor
Orna Therapeutics, Inc.
NCT07004296 Phase 1
Recruiting
A Study of HDM2005 in Patients With Advanced Solid Tumor
Condition
Advanced Solid Tumors
Enrollment
72 pts
Location
China
Sponsor
Hangzhou Zhongmei Huadong Phar
NCT05265546 Phase 1
Recruiting
Investigating the Mechanisms of the Effects of Psilocybin on Visual Perception a...
Condition
Perception Disorders
Enrollment
80 pts
Location
United States
Sponsor
University of California, Berk
NCT06090669 Phase 1
Recruiting
Imatinib to Increase RUNX1 Activity in Participants With Germline RUNX1 Deficien...
Condition
Inherited Bone Marrow Failure Syndrome
Enrollment
75 pts
Location
United States
Sponsor
National Cancer Institute (NCI
NCT07721402 Phase 1
Recruiting
A Study to Learn About How Different Forms of Study Medicine Prifetrastat Are Ta...
Condition
Healthy Participant
Enrollment
32 pts
Location
Belgium
Sponsor
Pfizer
NCT07040072 Phase 1
Recruiting
Finotonlimab Combined With Stapokibart in the Treatment of Recurrent/Metastatic ...
Condition
HNSCC
Enrollment
10 pts
Location
China
Sponsor
Beijing Tongren Hospital
NCT07807241 Phase 1
Recruiting
A Study of MX006 in Patients With Advanced and/or Metastatic Tumors Known to Exp...
Condition
Advanced and/or Metastatic Solid Tumors Known to Express B7-H3
Enrollment
120 pts
Location
United States
Sponsor
Myricx Pharma Limited
NCT06666283 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, PK and PD of AP303 in DKD Patients
Condition
Diabetic Kidney Disease
Enrollment
18 pts
Location
China
Sponsor
Alebund Pharmaceuticals
NCT07625345 Phase 1
Recruiting
Evaluation of [11C]ZTP-1 to Image PDE4B
Condition
Healthy
Enrollment
40 pts
Location
United States
Sponsor
National Institute of Mental H
NCT07481357 Phase 1
Recruiting
A First-In-Human Phase I/IIa Study to Evaluate DA 3501 in Patients With Advanced...
Condition
Gastric (Stomach) Cancer
Enrollment
51 pts
Location
South Korea
Sponsor
Dong-A ST Co., Ltd.
NCT04762199 Phase 1
Recruiting
MRX-2843 and Osimertinib for the Treatment of Advanced EGFR Mutant Non-small Cel...
Condition
Advanced Lung Non-Small Cell Carcinoma
Enrollment
69 pts
Location
United States
Sponsor
Emory University
NCT05856981 Phase 1
Recruiting
Phase 1 Study Evaluating the Safety and PK of ADU-1805 in Advanced Solid Tumors
Condition
Solid Tumor, Adult
Enrollment
130 pts
Location
United States, Belgium, Spain
Sponsor
Sairopa B.V.
NCT06944444 Phase 1
Recruiting
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignan...
Condition
Malignant Tumors
Enrollment
154 pts
Location
China
Sponsor
Shenyang Sunshine Pharmaceutic
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