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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

NCT06736327 Phase 1
Recruiting
A Study on the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of...
Condition
Advanced Solid Tumors
Enrollment
180 pts
Location
China
Sponsor
Sichuan Kelun-Biotech Biopharm
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NCT06896422 Phase 1
Recruiting
Randomized Trial of Glutathione With Anti-PD-1 and Chemotherapy in Advanced NSCL...
Condition
Non-Small Cell Lung Cancer
Enrollment
80 pts
Location
China
Sponsor
The First Affiliated Hospital
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NCT07695831 Phase 1
Recruiting
A Phase 1 Trial of GEN1119 in Participants With Solid Tumors
Condition
Solid Tumours
Enrollment
112 pts
Location
France, Japan, Spain
Sponsor
Genmab
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NCT07270770 Phase 1
Recruiting
BY002 IIT Study in R/R Acute Leukemia
Condition
Acute Leukemia
Enrollment
18 pts
Location
China
Sponsor
The First Affiliated Hospital
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NCT06672705 Phase 1
Recruiting
Epcoritamab for the Treatment of Relapsed or Refractory Post Transplant Lymphopr...
Condition
Diffuse Large B-Cell Lymphoma Post-Transplant Lymphoproliferative Disorder
Enrollment
26 pts
Location
United States
Sponsor
Timothy Voorhees
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NCT06686745 Phase 1
Recruiting
Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
130 pts
Location
China
Sponsor
Jiangsu Simcere Pharmaceutical
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NCT03802695 Phase 1
Recruiting
A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation fo...
Condition
Acute Myeloid Leukemia
Enrollment
300 pts
Location
United States
Sponsor
Orca Biosystems, Inc.
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NCT05661461 Phase 1
Recruiting
Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in ...
Condition
Tumor, Solid
Enrollment
28 pts
Location
United States
Sponsor
Aadi Bioscience, Inc.
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NCT07072169 Phase 1
Recruiting
A Study of mRNA Encoding CD19/CD3 T Cell Engager (ABO2203) in Patients With Rela...
Condition
B-cell Non-Hodgkin Lymphoma
Enrollment
56 pts
Location
China
Sponsor
Ruijin Hospital
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NCT07251153 Phase 1
Recruiting
Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation ...
Condition
Healthy Adult Male and Female Volunteers
Enrollment
40 pts
Location
France
Sponsor
Enyo Pharma
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NCT07343245 Phase 1
Recruiting
A Phase 1 Clinical Trial to Evaluate the Safety and DDI of DW4421 and 3 NSAIDs
Condition
Healthy Adult
Enrollment
150 pts
Location
South Korea
Sponsor
Daewon Pharmaceutical Co., Ltd
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NCT07694557 Phase 1
Recruiting
A Phase 1 Study to Evaluate the Safety, Reactogenicity and Immunogenicity of YKY...
Condition
Respiratory Syncytial Virus (RSV)
Enrollment
180 pts
Location
China
Sponsor
Beijing Youcare Kechuang Pharm
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NCT07414836 Phase 1
Recruiting
A First-in-Human Study of BG-C0979 in Adults With Advanced Solid Tumors
Condition
Advanced Solid Tumor
Enrollment
84 pts
Location
United States, Australia, China
Sponsor
BeOne Medicines
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NCT05471856 Phase 1
Recruiting
A Study to Test How Different Doses of BI 1703880 in Combination With Ezabenlima...
Condition
Solid Tumors
Enrollment
66 pts
Location
United States, Japan, Spain
Sponsor
Boehringer Ingelheim
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NCT04775745 Phase 1
Recruiting
Study of Oral Administration of LP-168 in Patients With Relapsed or Refractory B...
Condition
CLL/SLL
Enrollment
60 pts
Location
United States
Sponsor
Newave Pharmaceutical Inc
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NCT05388695 Phase 1
Recruiting
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of...
Condition
19 and 22+ B Cell Hematologic Tumors
Enrollment
100 pts
Location
China
Sponsor
Hebei Senlang Biotechnology In
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NCT07181681 Phase 1
Recruiting
A First-in-Human Study of BG-C0902 Alone and in Combination With Other Therapeut...
Condition
Solid Tumors
Enrollment
63 pts
Location
United States, Australia, China
Sponsor
BeOne Medicines
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NCT07541781 Phase 1
Recruiting
Sitagliptin in Recurrent/Progressive Grade 4 Glioma
Condition
Glioma
Enrollment
45 pts
Location
United States
Sponsor
Kailin Yang, MD, PhD
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NCT06848465 Phase 1
Recruiting
LDRT Combined With Immunochemotherapy for Colorectal Cancer With Liver Metastasi...
Condition
Colorectal Cancer
Enrollment
9 pts
Location
China
Sponsor
Daping Hospital and the Resear
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NCT06683365 Phase 1
Recruiting
Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synucli...
Condition
Multiple System Atrophy
Enrollment
7 pts
Location
United States
Sponsor
Craig van Horne, MD, PhD
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NCT07309900 Phase 1
Recruiting
IASO208 Injection in the Treatment of Relapsed/Refractory B-cell Malignancies
Condition
Relapsed/Refractory B-cell Malignancies
Enrollment
12 pts
Location
China
Sponsor
Union Hospital, Tongji Medical
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NCT06410092 Phase 1
Recruiting
Study in Patients With Advanced Solid Malignancies to Evaluate the Safety of FTL...
Condition
Solid Tumor
Enrollment
44 pts
Location
China
Sponsor
Sound Biopharmaceuticals Ltd.
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NCT06801002 Phase 1
Recruiting
Trial to Evaluate the Safety & Tolerability of JBZ-001 in Pts With Advanced Soli...
Condition
Solid Tumor
Enrollment
25 pts
Location
United States
Sponsor
Jabez Bioscience, Inc
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NCT06642181 Phase 1
Recruiting
Combined Guanfacine and Mindfulness Meditation as an Adjunct to Buprenorphine Ma...
Condition
Mindfulness
Enrollment
224 pts
Location
United States
Sponsor
Rutgers, The State University
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NCT07016971 Phase 1
Recruiting
CBG/CBD Oil for Chemotherapy-Induced Peripheral Neuropathy
Condition
Chemotherapy-Induced Peripheral Neuropathy
Enrollment
12 pts
Location
United States
Sponsor
Milton S. Hershey Medical Cent
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Page 5 of 23 — 575 trials total
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