NCT05371379

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

The study included screening period, administration and safety follow-up period. Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
BIOLOGICAL	CM338 Injection	A humanized monoclonal antibody.

Timeline

• Start date: 2022-05-24
• Primary completion: 2022-11-04
• Completion: 2022-11-04
• First posted: 2022-05-12
• Last updated: 2024-10-15

Locations

1 site across 1 country: China