Healthy
Conditions
Brief summary
This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.
Detailed description
The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.
Interventions
BIOLOGICALCM326
CM326 Injection
OTHERPlacebo
Subcutaneous injection
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 years and ≤ 65 years, healthy male. * With normal or abnormal laboratory test results without clinical significanceat screening period and baseline. * Subjects can communicate well with investigators and comply with protocol requirements.
Exclusion criteria
* Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period. * Major surgery is planned during the study period. * The average daily smoking volume is more than 5 cigarettes within 3 months before screening. * Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL. * There are any reasons that the investigator believes will prevent the subject from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emergency adverse events during treatment | Up to week 12 | By assessing the number and severity of adverse events during the study. |
Countries
China
Outcome results
None listed