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Recruiting Phase 2 NCT05775042

Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Trial Parameters

Condition IgA Nephropathy
Sponsor Keymed Biosciences Co.Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 70
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-05-08
Completion 2027-06-30
Interventions
CM338

Brief Summary

This study is a multicenter, randomized phase II clinical study to evaluate Efficacy and safety, while observing pharmacokinetic profiles, pharmacodynamic effects, and immunogenicity of CM338 in subjects with Immunoglobulin A(IgA) nephropathy.

Eligibility Criteria

Inclusion Criteria: * Male or female aged 18-75. * Understand the nature of the study and sign the Informed Consent Form voluntarily. * Take effective contraception measures throughout the study period. Exclusion Criteria: * Used other investigational drugs within 30 days before the first study administration. * With previous history of Human immunodeficiency virus(HIV) infection. * Treponema pallidum antibody positive in screening period. * May have active Mycobacterium tuberculosis infection. * Major surgery is planned during the study. * Other reasons the investigator believes that the subject is not suitable to participate in this study.

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