Study of CM313 in Healthy Subjects

Launched by KEYMED BIOSCIENCES CO.LTD · Feb 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CM313 to see how safe it is and how the body processes it. The trial is focused on healthy adult men aged 18 to 50 years. Participants will receive either CM313 or a placebo (a substance with no active ingredient) through an injection, either under the skin or directly into the bloodstream, while researchers carefully monitor their health.

To join the study, participants must be in good health without serious medical issues, especially no history of cancer or major surgeries planned during the trial. They also cannot have allergies to certain medications or drugs, and they should not smoke heavily or have recent substance use. If eligible, participants can expect to be part of a safe environment where their health and responses to the treatment will be closely watched. This study is currently looking for volunteers, and it aims to provide important information about CM313 that could help with future treatments.

Gender

MALE

Eligibility 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.