NCT03755258 is a Phase 1 clinical trial of GCK 300 mg in Early Rheumatoid Arthritis, sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd..

Who is sponsoring NCT03755258?

NCT03755258 is sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd..

What drugs are being tested in NCT03755258?

Interventions in NCT03755258: GCK 100 mg + Placebo 200 mg, GCK 200 mg + Placebo 100 mg, GCK 300 mg, Placebo 300mg.

What condition does NCT03755258 study?

NCT03755258 studies Early Rheumatoid Arthritis.

Is NCT03755258 still recruiting?

NCT03755258 is currently status unknown. Last updated 27 November 2018.

Last reviewed 2018-11-27 · How we verify

NCT03755258

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Status unknown Phase 1 Last updated 27 November 2018

What this trial tests

Phase 1 trial testing GCK 100 mg + Placebo 200 mg in Early Rheumatoid Arthritis in 128 participants. Status unknown.

Timeline

16 March 2017

Primary endpoint
11 July 2019

11 December 2019

Quick facts

Lead sponsor	Zhejiang Hisun Pharmaceutical Co. Ltd.
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	128
Start date	16 March 2017
Primary completion	11 July 2019
Estimated completion	11 December 2019
Sites	1 location across China

Drugs / interventions tested

GCK 100 mg + Placebo 200 mg — full drug profile →
GCK 200 mg + Placebo 100 mg — full drug profile →
GCK 300 mg — full drug profile →
Placebo 300mg — full drug profile →

Conditions studied

Early Rheumatoid Arthritis — all drugs for Early Rheumatoid Arthritis →

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd. — full company profile →

Who can join

Adults 18 to 65, any sex, with Early Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Systematic optimization of the yeast cell factory for sustainable and high efficiency production of bioactive ginsenoside compound K.
Wang P, Wang J, Zhao G, Yan X, et al · · 2021 · cited 33× · PMID 33869813 · DOI 10.1016/j.synbio.2021.03.002
Effect of Lactic Acid Bacteria on the Pharmacokinetics and Metabolism of Ginsenosides in Mice.
Jeon JH, Lee J, Park JH, Lee CH, et al · · 2021 · cited 19× · PMID 34575573 · DOI 10.3390/pharmaceutics13091496
Triterpenes as Potential Drug Candidates for Rheumatoid Arthritis Treatment.
Faustino C, Pinheiro L, Duarte N. · · 2023 · cited 18× · PMID 37511889 · DOI 10.3390/life13071514
Pharmacokinetics and Intestinal Metabolism of Compound K in Rats and Mice.
Jeon JH, Kang B, Lee S, Jin S, et al · · 2020 · cited 15× · PMID 32028741 · DOI 10.3390/pharmaceutics12020129
In vivo pharmacokinetics of ginsenoside compound K mediated by gut microbiota.
Deng MS, Huang ST, Xu YN, Shao L, et al · · 2024 · cited 2× · PMID 39178246 · DOI 10.1371/journal.pone.0307286

Verify or expand the search:

Other Zhejiang Hisun Pharmaceutical Co. Ltd. trials

Trials by the same sponsor.

NCT07310173 — Phase IIb Study of AST-3424 in Patients With AKR1C3-high Expressing Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07092748 — A Phase Ia/ Ib Study of HS387 in Subjects With Advanced Solid Tumors · Phase 1 · recruiting
NCT06048224 — Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of Recombinant Anti-interleukin-6 Receptor H · Phase 3 · completed
NCT03790982 — Evaluate the Safety and Efficacy of AD-35 Tablet in Subjects With Mild to Moderate Alzheimer's Disease · Phase 2 · unknown
NCT03636984 — Efficacy and Safety Study of Anbainuo in Chinese Patients With RA/AS in the Real World · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03755258 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Zhejiang Hisun Pharmaceutical Co. Ltd.
Last refreshed: 27 November 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03755258.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing