Study of CM313 in Healthy Subjects
A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion
1 other identifier
interventional
51
1 country
1
Brief Summary
This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously at different doses in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Mar 2024
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
February 29, 2024
CompletedStudy Start
First participant enrolled
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedOctober 16, 2024
February 1, 2024
1.1 years
February 22, 2024
October 14, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse event
Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Up to week 12
Study Arms (4)
Group 1
EXPERIMENTALCM313, subcutaneous injection, once
Group 2
EXPERIMENTALCM313, subcutaneous injection, once
Group 3
EXPERIMENTALCM313, subcutaneous injection, once
Group 4
EXPERIMENTALCM313, infusion, once
Interventions
Eligibility Criteria
You may qualify if:
- Subjects age ≥ 18 years \& ≤50 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
You may not qualify if:
- With history of malignant tumors;
- Plan to undergo major surgery during the research period
- Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
- With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
- The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
- Positive results in baseline alcohol breath test or urine drug abuse screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Huashan Hospital Fudan University
Shanghai, China
Related Publications (1)
Yu S, Wu J, Zhao J, He J, Yan H, Zhang X, Yang Y, Song H, Hou Q, Guo B, Qiu Y, Chen B, Xue Y, Zhang J. Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Participants: An Open-Label/Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial. Clin Transl Sci. 2025 Sep;18(9):e70334. doi: 10.1111/cts.70334.
PMID: 40965985DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Qing Zhang
Huashan Hospital
- PRINCIPAL INVESTIGATOR
Yu Xue
Huashan Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2024
First Posted
February 29, 2024
Study Start
March 12, 2024
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
October 16, 2024
Record last verified: 2024-02