Clinical trial NCT05668897: Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets
Official title: A Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose Ascending Phase Ia Clinical Trials in Healthy Subjects To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG171 Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: Fujian Akeylink Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-12-30
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
2. Ability to complete research in accordance with test plan requirements;
3. Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration;
4. Male and female healthy subjects aged 18 to 50 years (including 18 and 50 years old);
5. 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);
6. Physical examination, normal or abnormal vital signs have no clinical significance.

Exclusion Criteria:

1. Allergies (multiple drugs and food allergies);
2. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
3. 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);
4. Blood donation or massive blood loss (\> 400 mL) within three months before screening;
5. 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;
6. Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
7. Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
8. 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;
9. 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;
10. Vaccinated within 14 days before screening or planned to be vaccinated during the study;
11. 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;
12. 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);
13. Abnormal ECG has clinical significance;
14. Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
15. 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;
16. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
17. Acute disease or concomitant medication occurs from the screening stage to before study medication;
18. Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
19. People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
20. The investigator believes that there are other subjects who are not suitable for participating in this trial.

Primary outcomes:
measure: safety and tolerability
timeFrame: SAD up to Day 5 and MAD up to Day 9
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 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.
measure: Area Under Curve (AUC)
timeFrame: 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.
measure: T1/2
timeFrame: 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.
measure: Cl/F
timeFrame: 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.
measure: Ae(0~120h)
timeFrame: 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.
measure: Fe(0~120h)
timeFrame: 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.
Other outcomes:
Locations:
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
Study officials:
References: