Healthy
Conditions
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.
Interventions
BIOLOGICALCM313 injection
CM313
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 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Up to week 12 | Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) |
Countries
China
Contacts
Primary ContactQian Jia
Outcome results
None listed