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Phase 2
Age: 18Years - 75Years
All Genders
ID05775042

Phase II Study of CM338 Injection for Treating Immunoglobulin A Nephropathy in Adults Aged 18 to 75

Led by Keymed Biosciences Co.Ltd · Updated on 2024-10-15

70

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the effects of CM338 in adults with Immunoglobulin A IgA nephropathy, a kidney disease characterized by abnormal IgA deposits in the glomerulus. This randomized, multicenter Phase II clinical trial aims to evaluate the safety and effectiveness of CM338, while also monitoring how the drug behaves in the body, its biological effects, and the immune response it might trigger. The study is sponsored by Keymed Biosciences Co. Ltd. Participants will receive CM338 injections under the skin. The study includes multiple experimental groups, all receiving CM338 via subcutaneous injections. The trial will last up to 112 weeks, during which the participants reactions to the treatment and any side effects will be closely observed. During the study, participants will undergo regular assessments to monitor safety and treatment effects. Researchers will track adverse events related to CM338 and collect data on pharmacokinetics and pharmacodynamics. Participants must take effective contraception during the study. The total duration of participation is up to 112 weeks, including follow-ups to ensure ongoing safety and gather comprehensive data.

CONDITIONS

Brief Title

Clinical Study of CM338 in the Treatment of Immunoglobulin A Nephropathy

Research Team

Q

Qian Jia

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