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- || GST-HG171 / Fujian Cosunter
PK/PD data, Journal: Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. (Pubmed Central) - Jul 11, 2024
P1
GST-HG171 exhibited good safety and tolerability in the study. Taken together, mild to moderate hepatic impairment minimally impacted GST-HG171 exposure, suggesting no need to adjust GST-HG171 dosage for patients with mild to moderate hepatic impairment in the clinic.Clinical TrialsRegistered at ClinicalTrials.gov (NCT06106113).
- ||| Paxlovid (nirmatrelvir/ritonavir) / Pfizer
P2/3 data, Journal: Efficacy and safety of GST-HG171 in adult patients with mild to moderate COVID-19: a randomised, double-blind, placebo-controlled phase 2/3 trial. (Pubmed Central) - Apr 15, 2024
P2/3
As most patients were treated within 2 days after symptom onset in our study, confirming the potential benefits of symptom recovery for patients with a longer duration between symptom onset and treatment initiation will require real-world studies. Fujian Akeylink Biotechnology Co., Ltd.
- || GST-HG171 / Fujian Cosunter
Clinical, P1 data, Journal: Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. (Pubmed Central) - Dec 15, 2023
P1
The PK data obtained from GST-HG171/ritonavir administration guided the selection of appropriate dose for a pivotal phase II/III trial currently in progress. (This study has been registered at ClinicalTrials.gov under identifier NCT05668897).
- ||| GST-HG171 / Fujian Cosunter
Trial completion, Enrollment change: Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets (clinicaltrials.gov) - Oct 12, 2023
P1, N=78, Completed, Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
(This study has been registered at ClinicalTrials.gov under identifier NCT05668897). Recruiting --> Completed | N=130 --> 78
- ||| GST-HG171 / Fujian Cosunter
New P1 trial: Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets (clinicaltrials.gov) - Dec 30, 2022
P1, N=130, Recruiting, Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
- |||||||||| GST-HG171 / Fujian Cosunter
New P2/3 trial: Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19 (clinicaltrials.gov) - Dec 19, 2022
P2/3, N=1200, Not yet recruiting, Sponsor: Fujian Akeylink Biotechnology Co., Ltd.