NCT05324137

A Study of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

A Randomized, Double Blind, Placebo-controlled, Dose Escalation Phase 1b/2a Study to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity and Preliminary Efficacy of CM326 in Patients With Chronic Rhinosinusitis With Nasal Polyps

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, randomized, double blind, placebo-controlled, dose escalation study to evaluate the safety, tolerability, PK, PD, immunogenicity and preliminary efficacy of CM326 in patients with chronic rhinosinusitis with nasal polyps.

Detailed description

The study consists of 3 periods, a Screening Period, a Treatment Period and a Safety Follow-up Period. Subjects who meet eligibility criteria will be randomized to receive either CM326 or placebo subcutaneously.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
DRUG	CM326	CM326 injection
OTHER	Placebo	Placebo

Timeline

• Start date: 2022-07-11
• Primary completion: 2024-03-29
• Completion: 2024-03-29
• First posted: 2022-04-12
• Last updated: 2024-11-08

Locations

1 site across 1 country: China