Testing 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
This study is testing a new drug called CM383 in healthy men to see if it's safe and how it works, which could help in developing treatments for Alzheimer's disease.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT06412185 on ClinicalTrials.gov |
What this trial studies
This is a Phase I clinical study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of CM383 in healthy male volunteers. The study is randomized, double-blind, and placebo-controlled, ensuring that neither the participants nor the researchers know who receives the treatment or the placebo. The trial aims to gather essential data that could inform future studies on Alzheimer's disease treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy males aged 18 to 80 who can communicate effectively and adhere to the study protocol.
Not a fit: Patients with a history of significant smoking, excessive alcohol consumption, or drug abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new insights into the treatment of Alzheimer's disease.
How similar studies have performed: While this approach is common in early-phase trials, the specific compound CM383 has not been tested in this manner before.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Jinan, Shandong
- Jinan Central Hospital — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Qing Wen — Jinan Central Hospital
- Study coordinator: Qian Jia
- Email: qianjia@keymedbio.com
- Phone: 028-88610620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.