RecruitingPhase 2NCT05775042

Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

A Phase II Clinical Study Evaluating the Efficacy and Safety of CM338 Injection in Subjects With Immunoglobulin A Nephropathy

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

70 participants

Start Date

May 8, 2023

Study Type

INTERVENTIONAL

Conditions

IgA Nephropathy

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

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 Criteria6

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.