Multiple Ascending Dose Study of CM338 in Healthy Volunteers

A Multiple-dose, Randomized, Double Blind, Placebo-controlled, Dose-escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM338 Injection in Healthy Subjects

This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.

The study included screening period, administration and safety follow-up period.

Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Inclusion Criteria:

• Healthy male volunteers, aged ≥18 and ≤65 years.
• Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
• All clinical laboratory examination are normal, or abnormal without clinical significance.

Exclusion Criteria:

• Take any prescription medicine within 2 weeks before administration, or take any Chinese medicine or non-prescription medicine within 1 week.
• Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
• Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
• Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.