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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

589

Recruiting Now

589

Top Conditions in Phase 1

Advanced Solid Tumors (25) Advanced Solid Tumor (21) Healthy (18) Solid Tumor (16) Breast Cancer (14) Acute Myeloid Leukemia (13) Ovarian Cancer (13) Solid Tumors (12) Healthy Volunteers (11) Healthy Participants (11)

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

NCT07475572 Phase 1

Pharmacokinetic Similarity Study to Compare AVT32-DRL_PB With Keytruda® in Parti...

Alvotech Swiss AG

NCT07567222 Phase 1

Clinical Study of Novel Therapeutic Vaccine for Advanced Solid Tumors

Malignant Tumor

West China Hospital

NCT07226219 Phase 1

Methylphenidate to Address Attention and Executive Deficits Among Children With ...

Sickle Cell Disease

St. Jude Children's Research H

NCT07377175 Phase 1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BSY001 After...

China National Biotec Group Co

NCT05581030 Phase 1

CalPeg for Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

Acute Lymphoblastic Leukemia

H. Lee Moffitt Cancer Center a

NCT02897700 Phase 1

A Randomized Trial of Chemotherapy in Surgical Patients With Infiltrating Ductal...

Shanghai Jiao Tong University

NCT07551336 Phase 1

Dual-Targeting CAR-NK Cells for Recurrent/Progressive Glioblastoma and High-Grad...

Malignant Glioma

Beijing Biotech

NCT06479811 Phase 1

[212Pb]VMT-Alpha-NET in Metastatic or Inoperable Somatostatin-Receptor Positive ...

Sinonasal Neuroendocrine Carcinoma

National Cancer Institute (NCI

NCT06845839 Phase 1

Study to Evaluate CAY001 in Healthy Volunteers

Cayuga Biotech, Inc.

NCT07561554 Phase 1

Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation

Solid Tumors (Phase 1)

Haisco Pharmaceutical Group Co

NCT07114939 Phase 1

FTT PET/CT in Pancreatic Neuroendocrine Tumors

Neuroendocrine Carcinoma Metastatic

Abramson Cancer Center at Penn

NCT07462377 Phase 1

A Phase 1 Study of EPI-326 in EGFR-mutant NSCLC and HNSCC

Epidermal Growth Factor

United States, South Korea, Taiwan

NCT07555769 Phase 1

Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility...

Juan Luis Vásquez

NCT07737769 Phase 1

Arsenic Trioxide to Prevent Relapse in Patients Undergoing Allogeneic Stem Cell ...

Acute Myeloid Leukemia

University of Michigan Rogel C

NCT07542145 Phase 1

MDMA Assisted Therapy for BN

Bulimia Nervosa

Icahn School of Medicine at Mo

NCT07128303 Phase 1

Study of GS-5319 Given Alone or in Combination in Adults With Solid Tumors

Advanced Solid Tumor

United States, South Korea, Spain

Gilead Sciences

NCT06464861 Phase 1

Sequential Treatment of CD19 CARNK and 7x19 CAR-T in R/R B Cell Lymphoma

Primary Mediastinal B-cell Lymphoma (PMBCL)

Second Affiliated Hospital, Zh

NCT06614686 Phase 1

U87 CAR-T in Patients With Advanced Head and Neck Tumors

Nasopharynx Cancer

Shanghai Unicar-Therapy Bio-me

NCT07511205 Phase 1

A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynami...

Healthy Participants

United States, United Kingdom

NCT06005038 Phase 1

CogT pSOPT Intervention Study

Mild Cognitive Impairment

Stanford University

NCT07371338 Phase 1

Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of...

Parkinson Disease

Innopeutics Corporation

NCT07688252 Phase 1

Dinutuximab-beta and Chemotherapy in Newly Diagnosed High-Risk Neuroblastoma

High Risk Neuroblastoma

Chang Gung Memorial Hospital

NCT05703685 Phase 1

[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

National Institute of Mental H

NCT05691517 Phase 1

Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid...

Advanced Malignant Solid Neoplasm

National Cancer Institute (NCI

NCT06773091 Phase 1

A Phase I Study of NK042 Cell Injection in Advanced Solid Tumors

Advanced Solid Tumors

Shanghai NK Cell Technology Co

Page 4 of 24 — 589 trials total

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