Phase I Study of GST-HG151 Tablets in Healthy Volunteers

NCT05345964 | Unknown Phase 1

• 1 other identifier: GST-HG151-I-01
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (7)

• AEs and SAEs

  Safety assessments such as AEs and SAEs

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

• Peak Plasma Concentration (Cmax)

  Plasma samples were collected at different points for pharmacokinetic analysis

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

• Area Under Curve (AUC)

  Plasma samples were collected at different points for pharmacokinetic analysis

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

• T1/2

  Plasma samples were collected at different points for pharmacokinetic analysis

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

• Cl/F

  Plasma samples were collected at different points for pharmacokinetic analysis

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

• Ae

  Plasma samples were collected at different points for pharmacokinetic analysis

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

• Fe

  Plasma samples were collected at different points for pharmacokinetic analysis

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

Study Arms (6)

Single-dose experimental group

ACTIVE COMPARATOR

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

Single-dose control group

PLACEBO COMPARATOR

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

Multi-dose experimental group

ACTIVE COMPARATOR

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

Multi-dose control group

PLACEBO COMPARATOR

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

Food Impact Study Group A

ACTIVE COMPARATOR

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

Food Impact Study Group B

ACTIVE COMPARATOR

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

Drug: GST-HG151

Interventions

GST-HG151 DRUG

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

Single-dose experimental group

Placebo DRUG

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

Single-dose control group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial.
• Subjects (including partners) are willing to take effective pregnancy avoidance measures within 6 months after screening to the last study drug administration.
• Male and female healthy subjects aged 18 to 45 years (including 18 and 45 years old).
• 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).
• 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).

You may not qualify if:

• Allergic constitution (allergic to a variety of drugs, especially ingredients similar to the test drug, or excipients of the test drug, or food).
• 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.
• 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.
• Blood donation or massive blood loss (≥300 mL, , except female menstruation) or use blood products or blood transfusion within 3 months before screening.
• Have special requirements for diet and cannot abide by the unified diet.
• Took any prescription drugs, over-the-counter drugs, health products or Chinese herbal medicine within 2 weeks before screening.
• 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).
• 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.
• 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.
• 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.
• Ingested chocolate,any alcohol-containing product within 24 hours before screening.
• 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).
• Have a history of dysphagia or any gastrointestinal disease that affects drug absorption.
• 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).
• HBsAg, HCV, HIV and TPPA have one or more positive.

Sponsors & Collaborators

• Fujian Cosunter Pharmaceutical Co. Ltd: lead

Study Sites (1)

Mengchao Hepatpbiliary Hospital of Fujian Medical University

Fujian, Fuzhou, 350025, China

RECRUITING

Study Officials

• Ling Zheng, Bachelor

  Mengchao Hepatpbiliary Hospital of Fujian Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanan Tang, Master

CONTACT

+86 13585734994; annie_tyn@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 26, 2022
• Study Start: March 7, 2022
• Primary Completion: March 31, 2023
• Study Completion: May 31, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)