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Study of CM583 in Healthy Participants
Sponsor: Keymed Biosciences Co.Ltd
Summary
This is a randomized, double-blind, placebo-controlled, single-ascending-dose Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM583 in healthy adult participants. Approximately 40 participants will be enrolled in five dose cohorts. Within each cohort, participants will be randomized in a 3:1 ratio to receive a single subcutaneous dose of CM583 or placebo.
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Single Ascending Doses of CM583 in Healthy Adult Participants
Key Details
Gender
All
Age Range
18 Years - 45 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-10
Completion Date
2027-07
Last Updated
2026-09-16
Healthy Volunteers
Yes
Conditions
Interventions
CM583
CM583 injection administered SC(Subcutaneous), once
Placebo
Placebo injection administered SC, once
Locations (1)
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, Zhejiang, China