Study on the Tolerance and Pharmacokinetics of GST-HG141 Tablets

Last updated: June 1, 2020
Sponsor: Fujian Cosunter Pharmaceutical Co. Ltd
Overall Status: Active - Recruiting

Phase

1

Condition

Hepatitis B

Treatment

N/A

Clinical Study ID

NCT04386915
GST-2020-001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To Evaluate the Tolerability and Pharmacokinetics of GST-HG141 Tablets in Single-center, Randomized, Double-blind, Placebo-controlled Multiple-dose, Single-dose, Multiple-dose Phase Ia Clinical Trials in Healthy Subjects .

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. Ability to complete research in accordance with test plan requirements;

  3. Subjects (including partners) are willing to take effective pregnancy avoidancemeasures within 6 months after screening to the last study drug administration;

  4. Male and female healthy subjects aged 18 to 55 years (including 18 and 55 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 therange of 18 ~ 28 kg / m2 (including critical value);

  6. Physical examination, normal or abnormal vital signs have no clinical significance.

Exclusion

Exclusion Criteria:

  1. Those who smoked more than 5 cigarettes per day in the 3 months before the trial;

  2. Allergies (multiple drugs and food allergies);

  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 (> 450 mL) within three months before screening;

  5. Take any drug that changes the activity of liver enzymes 28 days before screening;

  6. Took any prescription drugs, over-the-counter drugs, any vitamin products, or herbswithin 14 days before screening;

  7. 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;

  8. Combined with inhibitors or inducers of CYP3A4, such as itraconazole, ketoconazole,etc.;

  9. Major changes in diet or exercise habits recently;

  10. Have taken the study drug or participated in the drug clinical trial within threemonths before taking the study drug;

  11. Have a history of dysphagia or any gastrointestinal disease that affects drugabsorption;

  12. Have any disease that increases the risk of bleeding, such as hemorrhoids, acutegastritis, or gastric and duodenal ulcers;

  13. Subjects who cannot tolerate a standard meal (two boiled eggs, a piece of butteredbacon toast, a box of fried potato strips, a cup of full-fat milk) (this strip is onlyapplicable to subjects participating in post-meal trials);

  14. Abnormal ECG has clinical significance;

  15. Female subjects were breastfeeding during the screening period or during the trial orwere preparing for pregnancy recently or had a positive serum pregnancy result;

  16. 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);

  17. Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen /antibody, and Treponema pallidum antibody;

  18. Acute disease or concomitant medication occurs from the screening stage to beforestudy medication;

  19. Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours beforetaking the study drug;

  20. Have taken any alcohol-containing product within 24 hours before taking the studydrug;

  21. People who have a positive urine drug screen or have a history of drug abuse or haveused drugs within the past five years;

  22. The investigator believes that there are other subjects who are not suitable forparticipating in this trial.

Study Design

Total Participants: 104
Study Start date:
May 18, 2020
Estimated Completion Date:
August 01, 2021

Study Description

This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies. To evaluate the tolerance of GST-HG141 tablets in healthy subjects in single and multiple administrations, pharmacokinetic characteristics, drug metabolism and transformation, and the effect of food on GST-HG141 pharmacokinetics.

Connect with a study center

  • The first hospital of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

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