Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To Evaluate the Safety, Tolerability and Pharmacokinetics on GST-HG171 Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical Trials in Healthy Subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose ascending group | Experimental | SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 6 subjects receive study drug. |
|
| SAD placebo comparator group | Placebo Comparator | SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 2 subjects receive placebo. |
|
| Multi-dose ascending group | Experimental | MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 6 subjects receive study drug. |
|
| MAD placebo comparator group | Placebo Comparator | MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive placebo. |
|
| Food effect study | Experimental | FE study cotains at least 1 cohort which were evaluated in SAD study to be tolerated . Each cohort enrolls 12 subjects receive study drug on fast or fed condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GST-HG171 | Drug | This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated. |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | SAD up to Day 5 and MAD up to Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The first hospital of Jilin University | Changchun | Jilin | 130021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38099673 | Derived | Zhang H, Zhou J, Chen H, Mao J, Tang Y, Yan W, Zhang T, Li C, Chen S, Li G, Zhang G, Ding Y, Liu L. Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0111523. doi: 10.1128/aac.01115-23. Epub 2023 Dec 15. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo of GST-HG171 | Drug | This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated. |
|
| Area Under Curve (AUC) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
| T1/2 | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
| Cl/F | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
| Ae(0~120h) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
| Fe(0~120h) | Plasma samples were collected at different points for pharmacokinetic analysis | Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |