NCT06285227

Study of CM313 in Healthy Subjects

A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	CM313 injection	CM313

Timeline

• Start date: 2024-03-12
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2024-02-29
• Last updated: 2024-10-16

Locations

1 site across 1 country: China