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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM512 in Patients With Chronic Rhinosinusitis With Nasal Polyposis
This is a multi-center, randomized, double blind, placebo-controlled Phase II study to evaluate the efficacy and safety of CM512, and to observe the life quality of subjects, the Pharmacokinetics, Pharmacodynamics and immunogenicity of CM512 in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP).
The study consists of a Screening Period (up to 4 weeks), Treatment Period (24 weeks for double-blind treatment period) and Safety Follow-up Period (12 weeks).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Beijing Tong-Ren hospital
Beijing, China
Start Date
May 16, 2025
Primary Completion Date
September 16, 2026
Completion Date
September 16, 2026
Last Updated
April 16, 2025
120
ESTIMATED participants
CM512
BIOLOGICAL
Placebo
DRUG
Lead Sponsor
Keymed Biosciences Co.Ltd
Data Source & Attribution
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