Phase I Study of GST-HG151 Tablets in Healthy Volunteers

Last updated: April 19, 2022
Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

N/A

Clinical Study ID

NCT05345964
GST-HG151-I-01
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Sign the informed consent before the trial and fully understand the content, processand possible adverse reactions of the trial.
  2. Subjects (including partners) are willing to take effective pregnancy avoidancemeasures within 6 months after screening to the last study drug administration.
  3. Male and female healthy subjects aged 18 to 45 years (including 18 and 45 years old).
  4. 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 therange of 19 ~ 24 kg / m2 (including critical value).
  5. Good physical condition (no significant clinical symptoms, normal physicalexamination. no clinically significant of laboratory examination, vital signs, 12 leadECG, chest film and abdominal B-ultrasound results).

Exclusion

Exclusion Criteria:

  1. Allergic constitution (allergic to a variety of drugs, especially ingredients similarto the test drug, or excipients of the test drug, or food).
  2. Smokers or those who smoke more than 5 cigarettes per day in the three months beforescreening, or disagree to avoid using any tobacco products during the study.
  3. Have a history of alcoholism or drink regularly in the three months before screening,those who drink more than 14 units of alcohol per week (1 unit = 360ml of beer with 5%alcohol content or 45ml of spirits with 40% alcohol content or 150ml of wine with 12%alcohol content). Who cannot stop alcohol intake during the study or have a positivebreath test for alcoho.
  4. Blood donation or massive blood loss (≥300 mL, , except female menstruation) or useblood products or blood transfusion within 3 months before screening.
  5. Have special requirements for diet and cannot abide by the unified diet.
  6. Took any prescription drugs, over-the-counter drugs, health products or Chinese herbalmedicine within 2 weeks before screening.
  7. Have taken the study drug or participated in the drug clinical trial within threemonths before taking the study drug(Except for those who did not enter the group).
  8. Take any drugs that alter liver enzyme activity CYP3A4, including strong inhibitorsand inducers that affect CYP3A4, within 28 days before screening or during the study.
  9. Female subjects were breastfeeding during the screening period or during the trial orwere preparing for pregnancy recently or had a positive serum pregnancy result.
  10. Have been smoking,drinking,or Ingested tea, any caffeinated or xanthine-rich food ordrink,or special diet (including dragon fruit, mango, grapefruit, etc.),or havevigorous exercise, or have other factors affecting drug absorption, distribution,metabolism, excretion, etc.within 48hours before screening.
  11. Ingested chocolate,any alcohol-containing product within 24 hours before screening.
  12. Subjects who cannot tolerate the standard meal (high fat and high calorie meal) (thisstrip is only applicable to subjects participating in the food impact study).
  13. Have a history of dysphagia or any gastrointestinal disease that affects drugabsorption.
  14. Clinical laboratory examinations are abnormal and clinically significant, or thefollowing diseases (including but not limited to gastrointestinal tract, kidney,liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovasculardisease).
  15. HBsAg, HCV, HIV and TPPA have one or more positive.
  16. had undergone major surgery within 4 weeks before screening or planned surgery duringthe trial.
  17. Have a history of drug abuse, or have used drugs within 3 months before screening, orthose who are positive in the screening test of urine drugs and drugs (methamphetamine, tetrahydrocannabinol acid, ketamine, cocaine, benzodiazepine,dimethylbisoxyamphetamine and morphine).
  18. Have difficulty in blood collection, or have a history of needle fainting or cannottolerate venipuncture.
  19. Cannot complete the trial for other reasons, or the investigator believes should notbe included.

Study Design

Total Participants: 112
Study Start date:
March 07, 2022
Estimated Completion Date:
May 31, 2023

Study Description

This trial includes single-dose studies,multiple-dose studies and food Impact studies, The single-dose study included eight doses groups of 5 mg, 15 mg, 30 mg, 60 mg, 90mg, 120 mg, 150 mg and 180 mg. Based on the results of a single dose, select 2 to 3 doses to conduct multiple dose studies. To evaluate the tolerance of GST-HG131 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG151 pharmacokinetics.

Connect with a study center

  • Mengchao Hepatpbiliary Hospital of Fujian Medical University

    Fujian, Fuzhou 350025
    China

    Active - Recruiting

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