Alzheimer Disease
Conditions
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.
Interventions
BIOLOGICALCM383
CM383 Injection
OTHERPlacebo
Placebo
Sponsors
Keymed Biosciences Co.Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | Up to week 12 | Incidence of adverse events. |
Countries
China
Contacts
Primary ContactQian Jia
Backup ContactQing Wen
Outcome results
None listed