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Status unknownNCT05345964Updated Apr 26, 2022

Phase I Study of GST-HG151 Tablets in Healthy Volunteers

A Phase 1 interventional study of GST-HG151 and Placebo in Healthy Volunteers, sponsored by Fujian Cosunter Pharmaceutical Co. Ltd. Status unknown at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-26.

Sponsored by Fujian Cosunter Pharmaceutical Co. Ltd · Phase 1, Interventional, and Other

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
112
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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

Read the detailed 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.

02

Conditions studied

  • Healthy Volunteers
03

In context

Lead sponsor

Fujian Cosunter Pharmaceutical Co. Ltd is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial.
  2. Subjects (including partners) are willing to take effective pregnancy avoidance measures 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 the range of 19 \~ 24 kg / m2 (including critical value).
  5. Good physical condition (no significant clinical symptoms, normal physical examination. no clinically significant of laboratory examination, vital signs, 12 lead ECG, chest film and abdominal B-ultrasound results).

Exclusion criteria

Exclusion Criteria:

  1. Allergic constitution (allergic to a variety of drugs, especially ingredients similar to 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 before screening, 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 positive breath test for alcoho.
  4. Blood donation or massive blood loss (≥300 mL, , except female menstruation) or use blood 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 herbal medicine within 2 weeks before screening.
  7. Have taken the study drug or participated in the drug clinical trial within three months 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 inhibitors and 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 or were 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 or drink,or special diet (including dragon fruit, mango, grapefruit, etc.),or have vigorous 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) (this strip is only applicable to subjects participating in the food impact study).
  13. Have a history of dysphagia or any gastrointestinal disease that affects drug absorption.
  14. Clinical laboratory examinations are abnormal and clinically significant, or the following diseases (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease).
  15. HBsAg, HCV, HIV and TPPA have one or more positive.
  16. had undergone major surgery within 4 weeks before screening or planned surgery during the trial.
  17. Have a history of drug abuse, or have used drugs within 3 months before screening, or those 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 cannot tolerate venipuncture.
  19. Cannot complete the trial for other reasons, or the investigator believes should not be included.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
112 participants (estimated)

Study arms

  • Active comparator
    Single-dose experimental group

    5mg,15mg,30mg,60mg,90mg,120mg,150mg and 180mg need to complete a single-dose clinical study. The first two dose groups had 4 subjects in each group (3 received GST-HG151 and 1 received placebo，randomly assigned), and the rest are 10 ubjects in each group (8 received GST-HG151 and 2 received placebo， randomly assigned)

    Drug: GST-HG151

  • Placebo comparator
    Single-dose control group

    5mg,15mg,30mg,60mg,90mg,120mg,150mg and 180mg need to complete a single-dose clinical study. The first two dose groups had 4 subjects in each group (3 received GST-HG151 and 1 received placebo，randomly assigned), and the rest are 10 ubjects in each group (8 received GST-HG151 and 2 received placebo， randomly assigned)

    Drug: Placebo

  • Active comparator
    Multi-dose experimental group

    According to the results of the SAD, it is planned to carry out multiple-dose studies in 2 to 3 dose groups. Continuous administration, 12 subjects in each group(10 received GST-HG151 and 2 received placebo， randomly assigned)

    Drug: GST-HG151

  • Placebo comparator
    Multi-dose control group

    According to the results of the SAD, it is planned to carry out multiple-dose studies in 2 to 3 dose groups. Continuous administration, 12 subjects in each group(10 received GST-HG151 and 2 received placebo， randomly assigned)

    Drug: Placebo

  • Active comparator
    Food Impact Study Group A

    According to the results of the SAD, it is planned to select 1 dose group，10 subjects(8 received GST-HG151 and 2 received placebo， randomly assigned)，two cycles, crossover

    Drug: GST-HG151

  • Active comparator
    Food Impact Study Group B

    According to the results of the SAD, it is planned to select 1 dose group，8 subjects，two cycles, crossover

    Drug: GST-HG151

Interventions

  • DrugGST-HG151

    Subjects will take GST-HG151 orally(once daily) on Day 1

  • DrugPlacebo

    Subjects will take Placebo orally(once daily) on Day 1

  • DrugGST-HG151

    Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7

  • DrugPlacebo

    Subjects will take Placebo orally (once daily) from day 1 to day 7

  • DrugGST-HG151

    Group A was administered under the fasting condition of Day1 in the first cycle, and under the postprandial conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.

  • DrugGST-HG151

    Group B was administered under the postprandial conditions of Day1 in the first cycle, and under the sky-abdominal conditions of Day8 \~ Day15 in the second cycle. The two cycles are cross-administered, and the cleaning period is 7 to 14 days.

06

What researchers measure

Primary outcomes

  1. AEs and SAEs

    Safety assessments such as AEs and SAEs

    Time frame: SAD Cohorts : Up to Day 6. MAD Cohorts : Up to Day 14. Food Effect Cohorts : Up to Day 20.

  2. Peak Plasma Concentration (Cmax)

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

  3. Area Under Curve (AUC)

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

  4. T1/2

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

  5. Cl/F

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

  6. Ae

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

  7. Fe

    Plasma samples were collected at different points for pharmacokinetic analysis

    Time frame: Before and at pre-specified time points up to 72 hours after dosing.

07

Study locations

1 of 1 sites recruiting
  • Mengchao Hepatpbiliary Hospital of Fujian Medical University
    Fujian, Fuzhou 350025, China
    • Ling Zheng, Bachelor · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05345964
Lead sponsor
Fujian Cosunter Pharmaceutical Co. Ltd
Responsible party
Sponsor
First posted
Apr 26, 2022
Start date
Mar 7, 2022
Primary completion
Mar 31, 2023 (estimated)
Completion
May 31, 2023 (estimated)
Last update
Apr 26, 2022

Study contacts

Yanan Tang, Master
Contact
annie_tyn@163.com
+86 13585734994
Ling Zheng, Bachelor
principal investigator · Mengchao Hepatpbiliary Hospital of Fujian Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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