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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
611
Recruiting Now
611
Top Conditions in Phase 1
Advanced Solid Tumor (29) Solid Tumor (21) Advanced Solid Tumors (19) Healthy (15) Healthy Volunteers (13) Healthy Volunteer (12) Colorectal Cancer (11) Triple Negative Breast Cancer (11) Solid Tumors (10) Ovarian Cancer (10)

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

NCT07580924 Phase 1
Recruiting
A Study of NHL907 in Healthy Adult Participants
Condition
Healthy Adult Participants
Enrollment
64 pts
Location
Australia
Sponsor
NeuHyll AUS Pty Ltd
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NCT06055361 Phase 1
Recruiting
A Study to Investigate the Safety, Tolerability, and Efficacy of BxC-I17e Single...
Condition
Atopic Dermatitis
Enrollment
45 pts
Location
United States
Sponsor
Brexogen Inc.
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NCT06293950 Phase 1
Recruiting
Allogeneic Wharton Jelly Mesenchymal Stromal Cell (WJMSC) for Treatment of Autis...
Condition
Autism
Enrollment
14 pts
Location
Jordan
Sponsor
University of Jordan
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NCT05497180 Phase 1
Recruiting
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep A...
Condition
Sleep Apnea, Obstructive
Enrollment
40 pts
Location
Canada
Sponsor
University of Alberta
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NCT06710379 Phase 1
Recruiting
A Study of ADRX-0405 in Subjects With Select Advanced Solid Tumors
Condition
Solid Tumors
Enrollment
68 pts
Location
United States
Sponsor
Adcentrx Therapeutics
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NCT07342491 Phase 1
Recruiting
Dasatinib for HIV-1 Reservoir Reduction
Condition
HIV Infections
Enrollment
14 pts
Location
United States
Sponsor
National Institute of Allergy
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NCT07203391 Phase 1
Recruiting
Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis
Condition
Uveal Melanoma, Metastatic
Enrollment
8 pts
Location
Australia
Sponsor
St Vincent's Hospital, Sydney
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NCT06401603 Phase 1
Recruiting
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With ...
Condition
Advanced Chronic Myeloid Leukemia
Enrollment
30 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
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NCT07226427 Phase 1
Recruiting
A First-in-Human Study of MEN2501 in Participants With Platinum-Resistant Ovaria...
Condition
Platinum-resistant Ovarian Cancer
Enrollment
100 pts
Location
United States
Sponsor
Stemline Therapeutics, Inc.
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NCT05978661 Phase 1
Recruiting
FKC288 for Relapsed or Refractory Systemic Light Chain (AL) Amyloidosis
Condition
Light Chain Amyloidosis
Enrollment
12 pts
Location
China
Sponsor
Nanjing University School of M
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NCT06546397 Phase 1
Recruiting
Study on the Effect of Combined Estrogen and Progestogen Therapy on Endometrial ...
Condition
Pregnancy Complications
Enrollment
200 pts
Location
China
Sponsor
Women's Hospital School Of Med
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NCT06559618 Phase 1
Recruiting
Bacteriophage Therapy in Spinal Cord Injury Patients With Bacteriuria
Condition
Bacteriuria
Enrollment
30 pts
Location
United States
Sponsor
Barbara Trautner
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NCT06816823 Phase 1
Recruiting
CAR-NK Cells (CL-NK-001) in Pancreatic Cancer
Condition
Pancreatic Cancer
Enrollment
30 pts
Location
China
Sponsor
Changhai Hospital
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NCT06169280 Phase 1
Recruiting
Repeated Neural Stem Cell Based Virotherapy for Newly Diagnosed High Grade Gliom...
Condition
Glioma, Malignant
Enrollment
20 pts
Location
United States
Sponsor
Northwestern University
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NCT07229313 Phase 1
Recruiting
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tu...
Condition
Advance Solid Tumors
Enrollment
76 pts
Location
United States, Australia
Sponsor
Kivu Bioscience Inc.
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NCT05324982 Phase 1
Recruiting
Pharmacokinetics and Pharmacodynamics of CHI-914 in Healthy Participants
Condition
Behavioral Pharmacology of Cannabis
Enrollment
30 pts
Location
United States
Sponsor
Johns Hopkins University
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NCT07155239 Phase 1
Recruiting
1726-nm Laser for Acne Inversa (Hidradenitis Suppurativa)
Condition
Hidradenitis Suppurativa (HS)
Enrollment
30 pts
Location
United States
Sponsor
Wynn Medical Center
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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
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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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NCT06031441 Phase 1
Recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of RO7566802 as a...
Condition
Locally Advanced Solid Tumors
Enrollment
250 pts
Location
United States, Australia, Canada
Sponsor
Genentech, Inc.
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NCT04815356 Phase 1
Recruiting
Phase I Study of Anti-CD22 Chimeric Receptor T Cells in Patients With Relapsed/R...
Condition
Hairy Cell Leukemia
Enrollment
27 pts
Location
United States
Sponsor
National Cancer Institute (NCI
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NCT06801470 Phase 1
Recruiting
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Ef...
Condition
Advanced Solid Tumors
Enrollment
137 pts
Location
China
Sponsor
CD (Suzhou) Biopharma Co., Ltd
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NCT06790394 Phase 1
Recruiting
Test-retest Study With [18F]FBB in Cardiac Amyloidosis
Condition
Cardiac Amyloidosis
Enrollment
15 pts
Location
United Kingdom
Sponsor
Lantheus Germany GmbH
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NCT06915753 Phase 1
Recruiting
Safety and Preliminary Anti-Tumor Activity of TYRA-430 in Advanced Hepatocellula...
Condition
Metastatic Hepatocellular Carcinoma
Enrollment
100 pts
Location
United States, Canada, South Korea
Sponsor
Tyra Biosciences, Inc
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NCT07444580 Phase 1
Recruiting
PrP-targeting siRNA Safety & Mechanism Study
Condition
Prion Disease
Enrollment
30 pts
Location
United States
Sponsor
Broad Institute of MIT and Har
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Page 5 of 25 — 611 trials total
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