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This is a phase Ib study to investigate the safety, pharmacokinetics and preliminary efficacy of ginsenoside compound K (GCK) tablets in patients with rheumatoid arthritis. This study is to be run in China involving 10-12 sites. It will enroll approximately 240 patients to ensure 128 randomized with active rheumatoid arthritis. The treatment period is 12 weeks and total study duration per patient is approximately 14 weeks.
In this double-blind, placebo-controlled, phase Ib study, 128 patients with active RA are planned to be enrolled and randomly assigned 1:1:1:1 to receive placebo, or different doses of GCK tablet (100/200/300 mg). This study will evaluate the safety, pharmacokinetics and preliminary efficacy of GCK tablets in patients with rheumatoid arthritis
Early Rheumatoid Arthritis
GCK 100 mg + Placebo 200 mg, GCK 200 mg + Placebo 100 mg, GCK 300 mg, Placebo 300mg
Department of Rheumatology
Zhejiang Hisun Pharmaceutical Co. Ltd.
Published on BioPortfolio: 2018-12-03T00:02:25-0500
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