Study of CM383 in Healthy Subjects
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of CM383 Following Intravenous and Subcutaneous Administration in Healthy Adult Subjects
Keymed Biosciences Co.Ltd
30 participants
Jan 1, 2026
INTERVENTIONAL
Conditions
Summary
This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.
Eligibility
Inclusion Criteria2
- Subjects age ≥ 18 years \& ≤54 years.
- Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Exclusion Criteria6
- The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening.
- Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
- History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
- Blood donation or any other form of blood loss exceeding 400 mL, or accepting blood transfusion within 12 weeks prior to screening.
- Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
- Severe trauma or undergo major surgery within 6 months prior to screening, or planned surgery during the research period.
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Interventions
CM383 subcutaneous injection, once.
CM383 intravenous infusion, once.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07292688