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NCT06106113

Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function

Completed Phase 1 Last updated 30 October 2023
What this trial tests

Phase 1 trial testing GST-HG171 Tablets in COVID-19 Pneumonia in 24 participants. Completed in 30 May 2023.

Timeline
15 December 2022
Primary endpoint
6 February 2023
30 May 2023

Quick facts

Lead sponsorFujian Akeylink Biotechnology Co., Ltd.
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment24
Start date15 December 2022
Primary completion6 February 2023
Estimated completion30 May 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other trials of GST-HG171 Tablets

Trials testing the same drug.

Other recruiting trials for COVID-19 Pneumonia

Currently open trials in the same condition.

Other Fujian Akeylink Biotechnology Co., Ltd. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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