Clinical Trial

Phase II Clinical Study to Evaluate the Efficacy and Safety of XKH001 Injection

Not Yet Recruiting Phase 2
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Summary
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, two-stage design, Phase II clinical study. This study is divided into two stages. Stage 1 (Phase IIa) has a dosing duration of 24 weeks (treatment period of 28 weeks) and aims to preliminarily evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD. Stage 2 (Phase IIb) has a dosing duration of 48 weeks (treatment period of 52 weeks) and aims to further evaluate the efficacy, safety, PK characteristics, and immunogenicity of XKH001 Injection in trial participants with moderate to severe COPD.
Trial Details
NCT Number NCT07519499
Lead Sponsor Zhejiang Kanova Biopharmaceutical Co., LTD
Conditions COPD
Enrollment 75 participants
Start Date 2026-04-01
Primary Completion 2027-12-01 (estimated)
Study Completion 2028-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-09