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NCT06106113
Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function
Phase 1 trial testing GST-HG171 Tablets in COVID-19 Pneumonia in 24 participants. Completed in 30 May 2023.
6 February 2023
Quick facts
| Lead sponsor | Fujian Akeylink Biotechnology Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 15 December 2022 |
| Primary completion | 6 February 2023 |
| Estimated completion | 30 May 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- GST-HG171 Tablets — full drug profile →
Conditions studied
- COVID-19 Pneumonia — all drugs for COVID-19 Pneumonia →
Sponsor
Fujian Akeylink Biotechnology Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, any sex, with COVID-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Inhibitors of SARS-CoV-2 Main Protease (Mpro) as Anti-Coronavirus Agents.
Zagórska A, Czopek A, Fryc M, Jończyk J. · · 2024 · cited 19× · PMID 39062511 · DOI 10.3390/biom14070797 -
Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function.
Zhou J, Zhang H, Chen H, Zhang G, et al · · 2024 · cited 4× · PMID 38990016 · DOI 10.1128/aac.00539-24
Verify or expand the search:
- PubMed search for NCT06106113
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GST-HG171 Tablets
Trials testing the same drug.
- NCT06106126 — Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function · NA · unknown
Other recruiting trials for COVID-19 Pneumonia
Currently open trials in the same condition.
- NCT06601998 — Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19. · recruiting
- NCT06501599 — AI-based System for Assessing Suspected Viral Pneumonia Related Lung Changes · recruiting
- NCT06402318 — Passive Detection- SARS-CoV-2 (COVID-19) A&M Breathalyzer (PROTECT Kiosk) for Operational Medicine · recruiting
- NCT05765396 — SARS-CoV-2/COVID-19 Study of Next Generation Non-Invasive Passive Detection Technologies · active not recruiting
- NCT06927622 — Corona Virus Disease 2019 Cohort Study · recruiting
Other Fujian Akeylink Biotechnology Co., Ltd. trials
Trials by the same sponsor.
- NCT07090759 — To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) · Phase 3 · recruiting
- NCT06263959 — A Randomized, Double-blind, Placebo-controlled Phase IIa Clinical Study to Evaluate the Safety and Efficacy of GST-HG131 · Phase 2 · recruiting
- NCT06087055 — Drug-Drug Interaction Study of Itraconazole With GST-HG171/Ritonavir in Healthy Participants · Phase 1 · completed
- NCT06084507 — Food Effects of GST-HG171 Tablets Combined With Ritonavir in Healthy Chinese Participants · Phase 1 · unknown
- NCT06106126 — Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06106113 (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 Fujian Akeylink Biotechnology Co., Ltd.
- Last refreshed: 30 October 2023
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/NCT06106113.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing