NCT07175506

Study of CM559 in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM559 in Healthy Subjects With Single Ascending Dose Administration

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Placebo	Placebo injection administered IV, once.
BIOLOGICAL	CM559	CM559 injection administered IV, once.

Timeline

• Start date: 2025-09-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2025-09-16
• Last updated: 2025-09-29

Locations

1 site across 1 country: China