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
NCT07067385 Phase 1
Recruiting
Personalized mRNA Cancer Vaccine for Gastrointestinal Solid Tumor Treatment
Condition
Personalized Neoantigen Vaccine in Combination With Anti-PD-1 Inhibitors in Standard Therapy-Failed and Adjuvant Therapy
Enrollment
40 pts
Location
China
Sponsor
Ruijin Hospital
NCT03729752 Phase 1
Recruiting
PET Imaging of Radiolabeled Anti-HIV-1 Envelope Monoclonal Antibody (VRC01)
Condition
HIV-1-infection
Enrollment
30 pts
Location
United States
Sponsor
University of California, San
NCT07411755 Phase 1
Recruiting
A Phase 1 Clinical Study Comparing GS101 and Dupixent® After Subcutaneous Inject...
Condition
Atopic Dermatitis (AD)
Enrollment
294 pts
Location
China
Sponsor
Jiangsu Genscend Biopharmaceut
NCT07713485 Phase 1
Recruiting
Study of XmAb412 in Healthy Participants
Condition
Not Applicable - Healthy Adult Participants
Enrollment
128 pts
Location
Australia
Sponsor
Xencor, Inc.
NCT03595917 Phase 1
Recruiting
ABL001 + Dasatinib + Prednisone + Blinatumomab in BCR-ABL+ B-ALL or CML
Condition
B-cell Acute Lymphoblastic Leukemia
Enrollment
40 pts
Location
United States
Sponsor
Marlise Luskin, MD
NCT06414889 Phase 1
Recruiting
Protocol Title: Safety and Feasibility of Autologous CD34+ Hematopoietic Stem Ce...
Condition
RUNX1 Familial Platelet Disorder
Enrollment
4 pts
Location
United States
Sponsor
M.D. Anderson Cancer Center
NCT07330778 Phase 1
Recruiting
A Study of CDX-622 in Participants With Mild to Moderate Asthma
Condition
Mild to Moderate Asthma
Enrollment
12 pts
Location
United States
Sponsor
Celldex Therapeutics
NCT07600476 Phase 1
Recruiting
A First-in-Human Study to Evaluate the Safety, Pharmacokinetics and Pharmacodyna...
Condition
Cutaneous Melanoma
Enrollment
21 pts
Location
Germany
Sponsor
Kupando GmbH
NCT06095089 Phase 1
Recruiting
A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancer
Condition
Prostatic Neoplasms
Enrollment
355 pts
Location
United States, Australia, China
Sponsor
Janssen Research & Development
NCT07136389 Phase 1
Recruiting
Safety, Pharmacokinetics, Immunogenicity BCD-256-1 and Divozilimab in Subjects W...
Condition
Systemic Lupus Erthematosus
Enrollment
135 pts
Location
Russia
Sponsor
Biocad
NCT07705035 Phase 1
Recruiting
DBC-664 in Adult Patients With Solid Tumors
Condition
Malignant Germ Cell Tumor
Enrollment
210 pts
Location
United States
Sponsor
Duboce Biopharmaceuticals, Inc
NCT06092580 Phase 1
Recruiting
Phase 1 Study of AWT020 in Advanced Cancer
Condition
Advanced Cancer
Enrollment
60 pts
Location
Australia
Sponsor
Anwita Biosciences
NCT06953453 Phase 1
Recruiting
A Study of Inhaled Fentanyl Aerosol in Chinese Patients With Malignant Tumors
Condition
Cancer
Enrollment
100 pts
Location
China
Sponsor
Lee's Pharmaceutical Limited
NCT06966388 Phase 1
Recruiting
Study to Evaluate the Feasibility of Twice Daily Use of Topical Azelaic Acid in ...
Condition
Breast Cancer
Enrollment
33 pts
Location
United States
Sponsor
Virginia Commonwealth Universi
NCT07476586 Phase 1
Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in H...
Condition
Healthy Volunteers
Enrollment
44 pts
Location
China
Sponsor
Changchun GeneScience Pharmace
NCT05656573 Phase 1
Recruiting
CART-PSMA Cells for Advanced Prostate Cancer
Condition
Prostate Cancer
Enrollment
20 pts
Location
China
Sponsor
Nova Therapeutics LLC
NCT06736054 Phase 1
Recruiting
A Phase I Trial of 61Cu-NODAGA-PSMA for Patients with Prostate Cancer
Condition
Prostate Adenocarcinoma
Enrollment
8 pts
Location
United States
Sponsor
Hoag Memorial Hospital Presbyt
NCT07052305 Phase 1
Recruiting
NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel...
Condition
Large B-cell Lymphoma
Enrollment
24 pts
Location
United States
Sponsor
Washington University School o
NCT06613360 Phase 1
Recruiting
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, ...
Condition
SLE
Enrollment
24 pts
Location
United States, Australia, Bulgaria
Sponsor
Cullinan Therapeutics Inc.
NCT06307795 Phase 1
Recruiting
A Study to Investigate ANS014004 in Participants With Locally Advanced or Metast...
Condition
Locally Advanced or Metastatic Solid Tumors
Enrollment
63 pts
Location
United States, Canada, China
Sponsor
Avistone Biotechnology Co., Lt
NCT05054257 Phase 1
Recruiting
CART19 Cells Effects in Patients with Relapsed or Refractory Acute Lymphoblastic...
Condition
Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Enrollment
10 pts
Location
Czechia
Sponsor
Institute of Hematology and Bl
NCT06667141 Phase 1
Recruiting
Phase 1 Study of ACR-2316 in Specific Advanced Solid Tumors
Condition
Specific Advanced Solid Tumors
Enrollment
100 pts
Location
United States
Sponsor
Acrivon Therapeutics
NCT06896188 Phase 1
Recruiting
9-ING-41 Combined With Retifanlimab, Plus Modified FOLFIRINOX for Patients With ...
Condition
Pancreatic Adenocarcinoma
Enrollment
12 pts
Location
United States
Sponsor
Anwaar Saeed
NCT06662942 Phase 1
Recruiting
StrataMGT in the Reduction of Vulvar Lichen Sclerosus (LS) Symptoms
Condition
Vulvar Lichen Sclerosus
Enrollment
100 pts
Location
United States
Sponsor
Andrew T. Goldstein, MD
NCT07144254 Phase 1
Recruiting
Tegavivint With Gemcitabine in Patients With Relapsed or Refractory Osteosarcoma
Condition
Osteosarcoma Recurrent
Enrollment
24 pts
Location
United States
Sponsor
Emory University
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