Study of CM313 in Healthy Subjects
- Registration Number
- NCT06285227
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 51
Inclusion Criteria
- Subjects age ≥ 18 years & ≤50 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Exclusion Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 1 CM313 injection CM313, subcutaneous injection, once Group 2 CM313 injection CM313, subcutaneous injection, once Group 3 CM313 injection CM313, subcutaneous injection, once Group 4 CM313 injection CM313, infusion, once
- Primary Outcome Measures
Name Time Method Adverse event Up to week 12 Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Huashan Hospital Fudan University
🇨🇳Shanghai, China