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
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
NCT07195825 Phase 1
Recruiting
A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Tre...
Condition
PD
Enrollment
18 pts
Location
China
Sponsor
Shanghai Xinzhi BioMed Co., Lt
NCT07330674 Phase 1
Recruiting
A Phase 1 Study of ABF-101 in Single- and Multiple-Ascending Doses
Condition
Age Related Macular Degeneration (ARMD)
Enrollment
68 pts
Location
United States
Sponsor
Aptabio Therapeutics, Inc.
NCT06384352 Phase 1
Recruiting
Safety,Tolerability, Pharmacokinetics, and Efficacy of YL211 in Patients With Ad...
Condition
Advanced Solid Tumors
Enrollment
500 pts
Location
United States, Australia, Canada
Sponsor
MediLink Therapeutics (Suzhou)
NCT06882135 Phase 1
Recruiting
HW071021 Monotherapy in Patients With Advanced Solid Tumors
Condition
Advanced Solid Tumors
Enrollment
76 pts
Location
China
Sponsor
Wuhan Humanwell Innovative Dru
NCT06999187 Phase 1
Recruiting
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or ...
Condition
Triple Negative Breast Cancer
Enrollment
96 pts
Location
United States
Sponsor
Dren Bio
NCT07824349 Phase 1
Recruiting
JUR-003 in Adult Patients With Metastatic Prostate Cancer
Condition
Metastatic Castration Resistant Prostate Cancer
Enrollment
210 pts
Location
United States
Sponsor
Juri Biosciences, Inc.
NCT04038840 Phase 1
Recruiting
Imaging Synapses With [11C] UCB-J in the Human Brain
Condition
Schizophrenia
Enrollment
60 pts
Location
United States
Sponsor
Davidzon, Guido, M.D.
NCT07142278 Phase 1
Recruiting
DUVAX: A Phase 1 Alzheimer's Vaccine Study Targeting Amyloid-Beta and Tau
Condition
Alzheimer Disease
Enrollment
24 pts
Location
United States
Sponsor
Nuravax, Inc.
NCT07533708 Phase 1
Recruiting
A Phase I Clinical Study of HLX3902 in Patients With mCRPC and Other Advanced Tu...
Condition
mCRPC or Advanced/Metastatic Solid Tumors
Enrollment
48 pts
Location
China
Sponsor
Shanghai Henlius Biotech
NCT06476808 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses o...
Condition
High-grade Serous Ovarian Carcinoma (HGSOC)
Enrollment
240 pts
Location
United States, Canada, France
Sponsor
Bristol-Myers Squibb
NCT07180108 Phase 1
Recruiting
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
Condition
Psilocybin
Enrollment
100 pts
Location
United States
Sponsor
Johns Hopkins University
NCT07331389 Phase 1
Recruiting
A Drug-Drug Interaction Study of HDM1002 and Metformin, Empagliflozin, Midazolam...
Condition
Overweight Subject
Enrollment
111 pts
Location
China
Sponsor
Hangzhou Zhongmei Huadong Phar
NCT07058116 Phase 1
Recruiting
Accelerator-based BNCT (Boron Neutron Capture Therapy) for Head and Neck Carcino...
Condition
Head and Neck Carcinoma
Enrollment
10 pts
Location
Finland
Sponsor
Neutron Therapeutics, LLC
NCT06609083 Phase 1
Recruiting
Effect of Cannabis on Cigarette Use Behavior
Condition
Cannabis Use
Enrollment
100 pts
Location
United States
Sponsor
Johns Hopkins University
NCT06763341 Phase 1
Recruiting
A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Le...
Condition
Recurrent Acute Myeloid Leukemia
Enrollment
12 pts
Location
United States
Sponsor
City of Hope Medical Center
NCT05915013 Phase 1
Recruiting
Alpha-Amino-3-Hydroxy-5-Methyl-4- Isoxazole Propionic Acid Receptor Components o...
Condition
Depressive Disorder, Major
Enrollment
50 pts
Location
United States
Sponsor
Yale University
NCT07790562 Phase 1
Recruiting
A Study of Ferric Derisomaltose Injection in Chinese Participants With Iron Defi...
Condition
Iron Deficiency Anemia
Enrollment
88 pts
Location
China
Sponsor
Sichuan Huiyu Pharmaceutical C
NCT07189403 Phase 1
Recruiting
A Study of DS9051b in Participants With Advanced or Metastatic Adrenocortical Ca...
Condition
Advanced or Metastatic Adrenocortical Carcinoma
Enrollment
40 pts
Location
United States, France, United Kingdom
Sponsor
Daiichi Sankyo
NCT05860569 Phase 1
Recruiting
Safety Evaluation of Gene Therapy Drug in the Treatment of Primary Hypertriglyce...
Condition
Hypertriglyceridemia, Familial
Enrollment
7 pts
Location
China
Sponsor
GeneCradle Inc
NCT05883241 Phase 1
Recruiting
Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to B...
Condition
Bone Fracture
Enrollment
90 pts
Location
United States
Sponsor
ZetrOZ, Inc.
NCT07786441 Phase 1
Recruiting
KABAWIL: Reducing Intersectional Stigmas
Condition
Stigma, Social
Enrollment
120 pts
Location
United States
Sponsor
University of Washington
NCT07589205 Phase 1
Recruiting
Study of IBI3028 in Participants With Locally Advanced, Unresectable, or Metasta...
Condition
Solid Tumor
Enrollment
493 pts
Location
China
Sponsor
Innovent Biopharmaceutical Tec
NCT06882096 Phase 1
Recruiting
Tracing the Metabolic Flux of Orally Administered NAD+ Precursors
Condition
Healthy Adults
Enrollment
32 pts
Location
United States
Sponsor
Metro International Biotech, L
NCT07317505 Phase 1
Recruiting
A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
Condition
Cancer
Enrollment
270 pts
Location
United States
Sponsor
Conjupro Biotherapeutics, Inc.
NCT06925542 Phase 1
Recruiting
A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory ...
Condition
SLE (Systemic Lupus)
Enrollment
80 pts
Location
United States, Germany, Spain
Sponsor
CRISPR Therapeutics
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