NCT05186285

Single Ascending Dose Study of CM338 in Healthy Volunteers

A Single-dose, Randomized, Double Blind, Placebo-controlled, Dose-increasing Study to Evaluate the Safety, Tolerability, PK Characteristics, PD Effect, and Immunogenicity of CM338 Injection in Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study was a single-center, randomized, double blind, placebo-controlled, single-dose, dose-increasing study to evaluate the safety, tolerability, PK characteristics, PD effect, and immunogenicity of CM338 injection administered intravenously or subcutaneously at different doses in healthy subjects.

Detailed description

The study included screening period, baseline period, administration and hospitalization observation period, and safety follow-up period. Sixty-six healthy volunteers will be enrolled and randomized into 8 groups.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CM338	CM338 : a humanized monoclonal antibody.
DRUG	Placebo	Placebo.

Timeline

• Start date: 2021-12-11
• Primary completion: 2022-07-27
• Completion: 2022-07-27
• First posted: 2022-01-11
• Last updated: 2024-11-08

Locations

1 site across 1 country: China