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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

584

Recruiting Now

584

Top Conditions in Phase 1

Solid Tumor (25) Advanced Solid Tumor (25) Ovarian Cancer (14) Acute Myeloid Leukemia (14) Advanced Solid Tumors (12) Breast Cancer (10) Cervical Cancer (10) Hepatocellular Carcinoma (9) Endometrial Cancer (9) 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

NCT07357870 Phase 1

A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Se...

Turkey (Türkiye)

NCT06880380 Phase 1

The Efficacy and Safety Study of CAR-T Cells for Functional Cure in HIV-1/AIDS P...

HIV Infected Individuals

Institute of Hematology & Bloo

NCT07044050 Phase 1

A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural ...

Diffuse Large B-cell Lymphoma With no Other Specification

NCT04131413 Phase 1

HPV DNA Vaccine Via Electroporation for HPV16 Positive Cervical Neoplasia

Human Papillomavirus Type 16

Sidney Kimmel Comprehensive Ca

NCT07391670 Phase 1

A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacoki...

Australia, Georgia, Poland

NCT05864196 Phase 1

Two Fraction Prostate SBRT With DIL SIB

Prostate Cancer

NYU Langone Health

NCT04999761 Phase 1

AB122 Platform Study

Advanced or Metastatic Solid Tumor

Taiho Pharmaceutical Co., Ltd.

NCT07925983 Phase 1

A Study to Assess How Intravenous and Subcutaneous Administrations of Trosunilim...

Healthy Volunteer

NCT07275242 Phase 1

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid ...

Suzhou Suncadia Biopharmaceuti

NCT07741461 Phase 1

ACT201 Injection in Healthy Participants and Participants With Chronic Hepatitis...

Chronic Hepaititis B

Xiamen Amoytop Biotech Co., Lt

NCT05907980 Phase 1

A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents ...

United States, Japan

Chugai Pharmaceutical

NCT03832127 Phase 1

Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment o...

Nantes University Hospital

NCT07275073 Phase 1

JMT106 Injection in the Treatment of Advanced Solid Tumors

Advanced Solid Tumor

Shanghai JMT-Bio Inc.

NCT07275918 Phase 1

SA1211 Injection Phase 1 Study

Chronic Hepatitis B

Suzhou Siran Biotechnology Co.

NCT06639503 Phase 1

Genicular Nerve Block After Open Reduction Internal Fixation of Tibial Plateau

Tibial Plateau Fractures

University of Chicago

NCT07247110 Phase 1

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Malignant Neoplasm

United States, Australia, Canada

Merck Sharp & Dohme LLC

NCT06251310 Phase 1

SW-682 in Advanced Solid Tumors

Advanced Solid Tumor

SpringWorks Therapeutics, Inc.

NCT06992713 Phase 1

A Clinical Study Evaluating H1710 for Injection in Participants With Advanced So...

Advanced Solid Tumor

Shenzhen Hepalink Pharmaceutic

NCT07050459 Phase 1

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Soli...

Locally Advanced Solid Tumors

Jiangsu Simcere Pharmaceutical

NCT07096882 Phase 1

SDTM001 Injection as Adjuvant Therapy for NSCLC Patients After Radical Surgical ...

Non-Small Cell Lung Cancer

Cytocraft Biopharmaceutical Co

NCT07417124 Phase 1

Assess the Safety and Tolerability of SNS851 in Study Participants

Metabolic Disease

Oneness Biotech Co., Ltd.

NCT07574879 Phase 1

Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obst...

Chronic Obstructive Pulmonary Disease (COPD)

Zagazig University

NCT07658196 Phase 1

TLR9 Immunotherapy for Peritoneal Carcinomatosis

Malignant Ascites

Brown University

NCT07260812 Phase 1

KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Ly...

Non-Hodgkin Lymphoma

TCRx Therapeutics Co.Ltd

NCT07520292 Phase 1

Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder

Alcohol Use Disorder

Newleos Therapeutics, Inc.

Page 11 of 24 — 584 trials total

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