NCT03755258

Trial of Ginsenoside Compound K (GCK) Tablet in Patients With Rheumatoid Arthritis

A Phase Ib Study to Evaluate the Safety, Efficacy and Pharmacokinetics of GCK in Rheumatoid Arthritis Patients

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Early Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	GCK 100 mg + Placebo 200 mg	GCK 100 mg + Placebo 200 mg, oral, 12 weeks
DRUG	GCK 200 mg + Placebo 100 mg	GCK 200 mg + Placebo 100 mg, oral, 12 weeks
DRUG	GCK 300 mg	GCK 300 mg, oral, 12 weeks
DRUG	Placebo 300mg	Placebo 300mg, oral, 12 weeks

Timeline

• Start date: 2017-03-16
• Primary completion: 2019-07-11
• Completion: 2019-12-11
• First posted: 2018-11-27
• Last updated: 2018-11-27

Locations

1 site across 1 country: China