NCT06412185

Single Dose Escalation Study of CM383 in Healthy Volunteers

A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Dose Escalation of CM383 in Male Healthy Subjects

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.

Detailed description

Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	CM383	CM383 Injection
OTHER	Placebo	Placebo

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-06-30
• Completion: 2025-06-30
• First posted: 2024-05-14
• Last updated: 2024-11-08

Locations

1 site across 1 country: China