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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
The incidence of adverse events of CM338 in subjects with immunoglobulin A nephropathy — up to week 112 To evaluate the incidence of adverse events, including abnormalities of laboratory examination, physical examination, vital signs, 12-lead electrocardiogram (12-ECG) and others.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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