Overview

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.

Eligibility

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.