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Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Sponsored by Keymed Biosciences Co.Ltd

About this trial

Last updated 2 years ago

Study ID

CM338-105101

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting