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Study of Single and Multiple Ascending Doses of CM551 in Healthy Participants
Sponsor: Keymed Biosciences Co.Ltd
Summary
This is a randomized, double-blind, placebo-parallel controlled phase I study to evaluate the safety and tolerability of single and multiple doses of CM551 in healthy participants
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Single/Multiple Ascending Doses of CM551 in Healthy Participants
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-10
Completion Date
2027-09
Last Updated
2026-10-28
Healthy Volunteers
Yes
Interventions
CM551
Participants will receive single subcutaneous doses of CM551 solution in a dose escalation format across 4 sequential SAD cohorts.
Placebo
Participants will receive single subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 4 sequential SAD cohorts.
CM551
Participants will receive repeated subcutaneous doses of CM551 solution in a dose escalation format across 2 sequential MAD cohorts.
Placebo
Participants will receive repeated subcutaneous doses of CM551-matching placebo solution in a dose escalation format across 2 sequential MAD cohorts.
Locations (1)
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China