Healthy VolunteersPhase 1NCT05345964
Phase I Study of GST-HG151 Tablets in Healthy Volunteers
A Phase 1 study testing GST-HG151 in people with Healthy Volunteers, run by Fujian Cosunter Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GST-HG151
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 7 Mar 2022to 31 May 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
- had undergone major surgery within 4 weeks before screening or planned surgery during the trial.
- 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).
- Have difficulty in blood collection, or have a history of needle fainting or cannot tolerate venipuncture.
- Cannot complete the trial for other reasons, or the investigator believes should not be included.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Mengchao Hepatpbiliary Hospital of Fujian Medical University
Fujian, Fuzhou, 350025
Ling Zheng, Bachelor
About this study
Official title: A Safety, Tolerability, Pharmacokinetics, and Food Impact Phase I Study of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers
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.
- Conditions
- Healthy Volunteers
- Being tested
- GST-HG151, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG151Drug
Subjects will take GST-HG151 orally(once daily) on Day 1
PlaceboDrug
Subjects will take Placebo orally(once daily) on Day 1
GST-HG151Drug
Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7
PlaceboDrug
Subjects will take Placebo orally (once daily) from day 1 to day 7
GST-HG151Drug
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.
GST-HG151Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: 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 Receives: 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 Receives: Drug: GST-HG151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs and SAEs
Safety assessments such as AEs and SAEs
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Before and at pre-specified time points up to 72 hours after dosing.
Ae
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Before and at pre-specified time points up to 72 hours after dosing.
Fe
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Before and at pre-specified time points up to 72 hours after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start7 Mar 2022
- Primary completion31 Mar 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cosunter Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ling Zheng, Bachelor, Principal investigator, Mengchao Hepatpbiliary Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05345964
- Sponsor's protocol ID
- GST-HG151-I-01
- Status last verified
- Apr 2022
- First submitted
- 6 Apr 2022
- Last updated
- 26 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety, Tolerability, Pharmacokinetics, and Food Impact Phase I Study of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05345964
- Acronym / sponsor ID
- GST-HG151-I-01
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Fujian Cosunter Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 26 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Impact of GST-HG151 Tablets in Single-dose and Multiple-dose in Healthy Volunteers
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single-dose experimental group | Active comparator | Drug: GST-HG1515mg,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) |
| Single-dose control group | Placebo comparator | Drug: Placebo5mg,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) |
| Multi-dose experimental group | Active comparator | Drug: GST-HG151According 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) |
| Multi-dose control group | Placebo comparator | Drug: PlaceboAccording 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) |
| Food Impact Study Group A | Active comparator | Drug: GST-HG151According 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 |
| Food Impact Study Group B | Active comparator | Drug: GST-HG151According to the results of the SAD, it is planned to select 1 dose group，8 subjects，two cycles, crossover |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GST-HG151Subjects will take GST-HG151 orally(once daily) on Day 1 | Drug | Single-dose experimental group |
| PlaceboSubjects will take Placebo orally(once daily) on Day 1 | Drug | Single-dose control group |
| GST-HG151Subjects will take GST-HG151 orally (once daily) from Day 1 to Day 7 | Drug | Multi-dose experimental group |
| PlaceboSubjects will take Placebo orally (once daily) from day 1 to day 7 | Drug | Multi-dose control group |
| GST-HG151Group 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. | Drug | Food Impact Study Group A |
| GST-HG151Group 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. | Drug | Food Impact Study Group B |
Primary outcome
AEs and SAEs
Time frame: SAD Cohorts : Up to Day 6. MAD Cohorts : Up to Day 14. Food Effect Cohorts : Up to Day 20.
Safety assessments such as AEs and SAEs
Peak Plasma Concentration (Cmax)
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
Area Under Curve (AUC)
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
T1/2
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
Cl/F
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
Ae
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
Fe
Time frame: Before and at pre-specified time points up to 72 hours after dosing.
Plasma samples were collected at different points for pharmacokinetic analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Zheng, Bachelor principal investigator
Mengchao Hepatpbiliary Hospital of Fujian Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GST-HG151 in people with Healthy Volunteers, run by Fujian Cosunter Pharmaceutical Co. Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanan Tang, Master (+86 13585734994, annie_tyn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs and SAEs (time frame: SAD Cohorts : Up to Day 6. MAD Cohorts : Up to Day 14. Food Effect Cohorts : Up to Day 20.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2022.