Evaluating CM313 in Healthy Adults
A Randomized, Open/Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of CM313 in Healthy Subjects With Single Subcutaneous Injection/Intravenous Infusion
This study is testing a new drug called CM313 in healthy men to see how safe it is and how the body reacts to it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 51 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Male |
| Sponsor | Keymed Biosciences Co.Ltd Industry-sponsored |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT06285227 on ClinicalTrials.gov |
What this trial studies
This is a Phase 1 clinical study designed to assess the safety, tolerability, pharmacokinetics, and immunogenicity of CM313 in healthy male subjects. The study employs a randomized, open/double-blind, placebo-controlled approach, administering CM313 either subcutaneously or intravenously at varying doses. Participants will be monitored for their response to the treatment to gather data on how the drug behaves in the body and its potential side effects.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male adults aged between 18 and 50 years.
Not a fit: Patients with a history of malignant tumors or those planning major surgery during the study period may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of CM313, potentially leading to new treatment options.
How similar studies have performed: While this study is focused on a specific drug, similar Phase 1 studies have often shown success in establishing safety profiles for new treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subjects age ≥ 18 years \& ≤50 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * With history of malignant tumors; * Plan to undergo major surgery during the research period * Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients; * With any voluntary blood donation or any other form of blood loss exceeding 400 mL; * The average daily smoking volume within the first three months of screening is greater than 5 cigarettes; * Positive results in baseline alcohol breath test or urine drug abuse screening.
Where this trial is running
Shanghai
- Huashan Hospital Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Qing Zhang — Huashan 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.