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
Overview
- Phase
- Phase 1
- Intervention
- CM383
- Conditions
- Alzheimer Disease
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Adverse events
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group 1
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 1
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Group 2
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 2
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Group 3
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 3
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Group 4
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 4
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Group 5
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 5
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Group 6
CM383 injection and matched placebo, intravenous injection
Intervention: CM383
Group 6
CM383 injection and matched placebo, intravenous injection
Intervention: Placebo
Outcomes
Primary Outcomes
Adverse events
Time Frame: Up to week 12
Incidence of adverse events.