Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets

NCT05668897 | Completed Phase 1

• 1 other identifier: GST-HG171-I-01
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Peak Plasma Concentration (Cmax)

  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.

• Area Under Curve (AUC)

  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

  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

  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)

  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.

Study Arms (5)

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.

Drug: GST-HG171

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.

Drug: placebo of GST-HG171

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.

Drug: GST-HG171

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.

Drug: placebo of GST-HG171

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.

Drug: GST-HG171

Interventions

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.

Food effect study; Multi-dose ascending group; Single-dose ascending group

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.

MAD placebo comparator group; SAD placebo comparator group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
• Ability to complete research in accordance with test plan requirements;
• Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
• Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old);
• Male subjects weigh no less than 50 kg, and female subjects weigh no less than 45 kg. Body mass index (BMI) = body weight (kg) / height 2 (m2), body mass index is in the range of 18 \~ 28 kg / m2 (including critical value);
• Physical examination, normal or abnormal vital signs have no clinical significance.

You may not qualify if:

• Allergies (multiple drugs and food allergies);
• Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
• Have a history of drug abuse and / or alcoholism (drink 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
• Blood donation or massive blood loss (\> 400 mL) within three months before screening;
• Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause;
• Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
• Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
• Have Intended to take any drug that changes the activity of drug metabolizing enzyme 28 days before screening or during the study, including strong inhibitors and inducers that affect the metabolizing enzyme;
• Took any prescription drugs or herbs within 14 days before screening, or took over-the-counter drugs or any vitamin products within 7 days before screening;
• Vaccinated within 14 days before screening or planned to be vaccinated during the study;
• Those who have taken special diets (including dragon fruit, mango, grapefruit, etc.) or have vigorous exercise or other factors affecting drug absorption, distribution, metabolism, excretion, etc. within 2 weeks before screening;
• Those who cannot tolerate high fat (about 50% of the total calories) and high calorie (about 800\~1000 calories) standard meals (only applies to subjects participating in the food effect study);
• Abnormal ECG has clinical significance;
• Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
• Clinical laboratory examinations are abnormal and clinically significant, or find the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease) within 6 months before screening;

Sponsors & Collaborators

• Fujian Akeylink Biotechnology Co., Ltd.: lead

Study Sites (1)

The first hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Related Publications (1)

• 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.

  PMID: 38099673 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 30, 2022
• Study Start: October 1, 2022
• Primary Completion: December 2, 2022
• Study Completion: December 8, 2022
• Last Updated: October 12, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)