Single Dose Escalation Study of CM383 in Healthy Volunteers
- Registration Number
- NCT06412185
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 56
Inclusion Criteria
- Healthy males, voluntarily participate;
- 18 and 80 years old (including boundary values);
- able to communicate well with the researchers and follow up the protocol requirements.
Exclusion Criteria
- The average daily smoking volume within three months before screening is greater than 5 cigarettes;
- Excessive alcohol consumption within three months before screening, or positive alcohol breath test;
- Urine drug abuse screening is positive;
- Having a family planning or sperm donation plan; Disagree to adopt efficient contraceptive measures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Group 4 CM383 CM383 injection and matched placebo, intravenous injection Group 6 CM383 CM383 injection and matched placebo, intravenous injection Group 1 CM383 CM383 injection and matched placebo, intravenous injection Group 1 Placebo CM383 injection and matched placebo, intravenous injection Group 2 CM383 CM383 injection and matched placebo, intravenous injection Group 2 Placebo CM383 injection and matched placebo, intravenous injection Group 3 CM383 CM383 injection and matched placebo, intravenous injection Group 3 Placebo CM383 injection and matched placebo, intravenous injection Group 4 Placebo CM383 injection and matched placebo, intravenous injection Group 5 CM383 CM383 injection and matched placebo, intravenous injection Group 5 Placebo CM383 injection and matched placebo, intravenous injection Group 6 Placebo CM383 injection and matched placebo, intravenous injection
- Primary Outcome Measures
Name Time Method Adverse events Up to week 12 Incidence of adverse events.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jinan Central Hospital
🇨🇳Jinan, Shandong, China