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NOT YET RECRUITING
NCT07823764
PHASE1

Study of CM583 in Healthy Participants

Sponsor: Keymed Biosciences Co.Ltd

View on ClinicalTrials.gov

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

BIOLOGICAL

CM583

CM583 injection administered SC(Subcutaneous), once

DRUG

Placebo

Placebo injection administered SC, once

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medcine

Hangzhou, Zhejiang, China