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
NCT05065372 Phase 1
Recruiting
MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Va...
Condition
Type 1 Diabetes
Enrollment
60 pts
Location
United States
Sponsor
Kalie Tommerdahl
NCT06298019 Phase 1
Recruiting
Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis
Condition
Dermatomyositis
Enrollment
21 pts
Location
United States
Sponsor
Stanford University
NCT05802264 Phase 1
Recruiting
Study to Assess Amphotericin B Cystetic for Inhalation (ABCI) Doses in Healthy V...
Condition
Cystic Fibrosis
Enrollment
108 pts
Location
Australia, New Zealand
Sponsor
Cystetic Medicines, Inc.
NCT06046495 Phase 1
Recruiting
A Study of the Oral EGFR Inhibitor PLB1004 in Non-Small Cell Lung Cancer
Condition
Non-Small Cell Lung Cancer
Enrollment
81 pts
Location
United States
Sponsor
Avistone Biotechnology Co., Lt
NCT06184542 Phase 1
Recruiting
Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combi...
Condition
Diphtheria
Enrollment
460 pts
Location
China
Sponsor
Institute of Medical Biology,
NCT06783569 Phase 1
Recruiting
A First-in-Human Escalation and Expansion Study of Patients With Advanced Solid ...
Condition
Solid Tumors
Enrollment
94 pts
Location
China
Sponsor
JiaRay Group
NCT07661641 Phase 1
Recruiting
A Study of [177Lu]Lu-A9-0631 and [225Ac]Ac-A9-0642 With [68Ga]Ga-A9-6217 or [177...
Condition
Breast Cancer
Enrollment
115 pts
Location
Australia
Sponsor
Alpha-9 Oncology USA Inc.
NCT05504837 Phase 1
Recruiting
A Study Assessing KB407 for the Treatment of Cystic Fibrosis
Condition
Cystic Fibrosis
Enrollment
20 pts
Location
United States
Sponsor
Krystal Biotech, Inc.
NCT05917145 Phase 1
Recruiting
ATM-Inhibitor WSD0628 in Combination With Radiation Therapy for Treatment of Rec...
Condition
Glioblastoma
Enrollment
94 pts
Location
United States
Sponsor
Mayo Clinic
NCT06892054 Phase 1
Recruiting
Sotorasib Combined With First-line Chemotherapy for Advanced Pancreatic Adenocar...
Condition
Pancreatic Adenocarcinoma
Enrollment
15 pts
Location
France, Spain
Sponsor
Spanish Cooperative Group for
NCT03760575 Phase 1
Recruiting
Pembrolizumab in Combination With Chemotherapy and Image-Guided Surgery for Mali...
Condition
Mesotheliomas Pleural
Enrollment
20 pts
Location
United States
Sponsor
Abramson Cancer Center at Penn
NCT05630794 Phase 1
Recruiting
Testing for Safety and Colorectal Cancer Preventive Effects of ONC201
Condition
Colorectal Adenomatous Polyp
Enrollment
36 pts
Location
United States
Sponsor
National Cancer Institute (NCI
NCT07248839 Phase 1
Recruiting
A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With ...
Condition
Healthy Volunteers
Enrollment
24 pts
Location
United States
Sponsor
Bristol-Myers Squibb
NCT06932705 Phase 1
Recruiting
A Study to Compare to PK Characteristics and Safety Profiles Between PA-111 and ...
Condition
Mixed Dyslipidemia
Enrollment
48 pts
Location
South Korea
Sponsor
Addpharma Inc.
NCT02889666 Phase 1
Recruiting
A Randomised Trial of Chemotherapy Plus Surgery for Recurrent Non-Small Cell Lun...
Condition
Recurrent Non-small Cell Lung Cancer
Enrollment
500 pts
Location
China
Sponsor
Shanghai Jiao Tong University
NCT07646106 Phase 1
Recruiting
THE-0504 in Patients With Solid Tumors
Condition
Small Cell Lung Cancer (SCLC)
Enrollment
30 pts
Location
Italy
Sponsor
Thena Biotech S.r.l.
NCT07141706 Phase 1
Recruiting
A Study of DB-1317 in Selected Advanced/Metastatic Solid Tumors
Condition
Advanced/Metastatic Solid Tumors
Enrollment
253 pts
Location
United States, Australia, China
Sponsor
DualityBio Inc.
NCT06911008 Phase 1
Recruiting
MTI-301 for the Treatment of Metastatic or Unresectable and Refractory Solid Can...
Condition
Metastatic Malignant Solid Neoplasm
Enrollment
42 pts
Location
United States
Sponsor
Mayo Clinic
NCT07508020 Phase 1
Recruiting
A Research Study Looking at How NNC0487-0111 Affects Food Intake, Appetite and M...
Condition
Obesity
Enrollment
120 pts
Location
Germany
Sponsor
Novo Nordisk A/S
NCT06363006 Phase 1
Recruiting
Combination of Cardonizumab Injection and TKI Second Line Therapy for Advanced H...
Condition
Hepatocellular Carcinoma
Enrollment
40 pts
Location
China
Sponsor
Peking Union Medical College H
NCT05210374 Phase 1
Recruiting
Disulfiram With Copper Gluconate and Liposomal Doxorubicin in Treatment-Refracto...
Condition
Relapsed Sarcomas
Enrollment
24 pts
Location
United States
Sponsor
Case Comprehensive Cancer Cent
NCT05304962 Phase 1
Recruiting
FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Nega...
Condition
Breast Cancer
Enrollment
64 pts
Location
United States
Sponsor
Regor Pharmaceuticals Inc.
NCT05704361 Phase 1
Recruiting
A Study to Investigate the Safety, Tolerability, and Processing by the Body of I...
Condition
Multiple Sclerosis
Enrollment
119 pts
Location
United States, Belgium, Canada
Sponsor
Hoffmann-La Roche
NCT06880380 Phase 1
Recruiting
The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS P...
Condition
HIV Infected Individuals
Enrollment
3 pts
Location
China
Sponsor
Institute of Hematology & Bloo
NCT07453862 Phase 1
Recruiting
Novel Calcium Channel Modulators in RLS and Variants: Efficacy & Safety
Condition
Restless Leg Syndrome (RLS)
Enrollment
20 pts
Location
China
Sponsor
Beijing Friendship Hospital
ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer · Last Reviewed: September 2026 · Data Methodology