Evaluation of GST-HG121 Tablets for Safety and Pharmacokinetics

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of GST-HG121 Tablets in Single and Multiple Administration in Chinese Adult Healthy Subjects

This study is testing a new tablet called GST-HG121 in healthy Chinese adults to see if it's safe, how well it works in the body, and how food affects its absorption.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 114 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: Fujian Akeylink Biotechnology Co., Ltd. (industry)
• Locations: 1 site (Changchun, Jilin)
• Trial ID: NCT05576584 on ClinicalTrials.gov

What this trial studies

This phase I clinical study evaluates the safety, tolerability, and pharmacokinetic characteristics of GST-HG121 tablets in healthy Chinese adults. The study is divided into three parts: a single dose escalation study, a multiple dose escalation study, and an investigation of food effects on drug absorption. Participants will receive either the drug or a placebo in a randomized, double-blind manner, with assessments made on the impact of food on pharmacokinetics. The study aims to determine the maximum applicable dose and how food intake affects the drug's characteristics.

Who should consider this trial

Good fit: Ideal candidates are healthy Chinese adults aged 18 to 55 who meet specific weight and BMI criteria.

Not a fit: Patients with a history of respiratory, circulatory, or digestive diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safe dosage and absorption characteristics of GST-HG121 tablets, potentially leading to improved treatment options.

How similar studies have performed: While this approach is common in pharmacokinetic studies, the specific evaluation of GST-HG121 tablets is novel and has not been previously tested.

Eligibility criteria

Inclusion Criteria:

1. The subjects must give informed consent to the test before the test, fully understand the test content, process and possible adverse reactions, and voluntarily sign a written informed consent;
2. Able to complete the research according to the requirements of the test scheme;
3. Chinese male and female subjects aged between 18 and 55 years old (both inclusive).
4. The weight of male subjects shall not be less than 50kg and that of female subjects shall not be less than 45kg. Body mass index (BMI) = body weight (kg) / height 2 (M2), and the body mass index is within the range of 18-28 kg / m2 (including the critical value);
5. Effective contraceptive measures can be taken within 6 months from the start of screening to the last administration of the trial drug, and sperm and eggs donation shall be avoided during this period. See Appendix 5 for specific contraceptive measures;
6. At the time of screening, there was no history of respiratory, circulatory, digestive, urinary, blood, endocrine, nervous system diseases and metabolic abnormalities with clinical significance;
7. At the time of screening, the results of vital signs, physical examination, laboratory examination, electrocardiogram, abdominal color ultrasound (liver, gallbladder, spleen, pancreas, double kidneys) and chest X-ray (positive position) examination were normal or abnormal but judged by the investigator to have no clinical significance.

Exclusion Criteria:

1. Hospitalization within 30 days before the trial administration, or surgical operation within 6 months before the trial administration, or the presence of transplanted organs in the body, or any medical condition that is not suitable for participating in the trial according to the judgment of the investigator;
2. Those who have participated in other intervention clinical trials and used clinical study drugs within 3 months before the trial administration or plan to participate in other clinical studies at the same time during the study (if the subjects withdraw from the study before treatment, that is, they are not randomized or treated, they can be included in the study);
3. Have been vaccinated with live vaccine within 3 months before the trial administration, or need to be vaccinated during the study period;
4. Clinically significant drug allergy history or specific allergic disease history (asthma, urticaria) or known allergy to the test drug or its excipients;
5. Blood donation or massive blood loss (\> 450 ml) or use of blood products or blood transfusion within three months before screening;
6. Those who smoked more than 5 cigarettes per day on average 3 months before the trial;
7. The subjects had a history of alcoholism within 12 months before the screening (drinking 14 units of alcohol every week: 1 unit = 285 ml of beer, 25 ml of liquor, or 100 ml of wine), or the subjects could not use any alcohol containing products within 72 hours before the test administration and during the whole test, or the subjects were positive in the alcohol breath test during the screening period;
8. Those with positive urine drug screening (morphine, marijuana) or drug abuse history;
9. Taking any prescription medicine, over-the-counter medicine, any health product or herbal medicine within 14 days before screening; Any drug that alters liver enzyme activity was taken 28 days before screening; Inhibitors or inducers combined with the following CYP3A4, P-gp or BCRP, such as itraconazole, ketoconazole or dronedarone;
10. Those who have taken special diet (including pitaya, mango, grapefruit, etc.) or had vigorous exercise or other factors affecting drug absorption, distribution, metabolism and excretion within 2 weeks before screening;
11. Recent major changes in diet or exercise habits;
12. Have a history of dysphagia or any gastrointestinal disease affecting drug absorption;
13. Suffering from any disease that increases the risk of bleeding, such as hemorrhoids, gastritis or gastric and duodenal ulcers;
14. Subjects who cannot tolerate standard meals (high-fat and high calorie meals) (this article is only applicable to subjects participating in food impact studies);
15. Female subjects are breastfeeding or preparing to become pregnant in the near future during the screening period or the test process, or the serum pregnancy results are positive;
16. Screening positive for hepatitis B surface antigen, hepatitis C antibody, AIDS antibody and Treponema pallidum antibody;
17. Ingestion of chocolate, any food or drink containing alcohol, caffeine or xanthine 24 hours before taking the study drug;
18. Subjects considered by the investigator to have other factors unsuitable for participating in the trial.

Where this trial is running

Changchun, Jilin

• The first hospital of Jilin University — Changchun, Jilin, China (RECRUITING)

Study contacts

• Study coordinator: Yanhua Ding, Dr.

Conditions: Pharmacokinetics, Food Affect, Single Ascending Dose, Maximum Applicable Dose, food affects