COVID-19Phase 1NCT05668897
Safety, Tolerability and Pharmacokinetic Characteristics Evaluation on GST-HG171 Tablets
A Phase 1 study testing GST-HG171 in people with COVID-19, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial summary
To Evaluate the Safety, Tolerability and Pharmacokinetics on GST-HG171 Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical Trials in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- GST-HG171
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 8 Dec 2022
- 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 50 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;
- Ability to complete research in accordance with test plan requirements;
- 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 50 years (including 18 and 50 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 18 ~ 28 kg / m2 (including critical value);
- Physical examination, normal or abnormal vital signs have no clinical significance.
Who cannot join
- Allergies (multiple drugs and food allergies);
- Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
- 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);
- Blood donation or massive blood loss (> 400 mL) within three months before screening;
- Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause;
- Have any disease that increases the risk of bleeding, such as hemorrhoids, acute gastritis, or gastric and duodenal ulcers;
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- Have taken the study drug or participated in the drug clinical trial within three months before taking the study drug;
- Have Intended to take any drug that changes the activity of drug metabolizing enzyme 28 days before screening or during the study, including strong inhibitors and inducers that affect the metabolizing enzyme;
- Took any prescription drugs or herbs within 14 days before screening, or took over-the-counter drugs or any vitamin products within 7 days before screening;
- Vaccinated within 14 days before screening or planned to be vaccinated during the study;
- 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;
- Those who cannot tolerate high fat (about 50% of the total calories) and high calorie (about 800~1000 calories) standard meals (only applies to subjects participating in the food effect study);
- Abnormal ECG has clinical significance;
- Female subjects were breastfeeding or had a positive serum pregnancy result during the screening period or during the study;
- Clinical laboratory examinations are abnormal and clinically significant, or find the following diseases with clinical significance (including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, Immune, mental or cardiovascular disease) within 6 months before screening;
- Positive screening for viral hepatitis (including hepatitis B and C), AIDS antigen / antibody, and Treponema pallidum antibody;
- Acute disease or concomitant medication occurs from the screening stage to before study medication;
- Ingested chocolate, any caffeinated or xanthine-rich food or drink 24 hours before taking the study drug;
- People who have a positive urine drug screen or have a history of drug abuse or have used drugs within the past five years;
- The investigator believes that there are other subjects who are not suitable for participating in this trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose Ascending Phase Ia Clinical Trials in Healthy Subjects To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG171 Tablets
To Evaluate the Safety, Tolerability and Pharmacokinetics on GST-HG171 Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical Trials in Healthy Subjects
- Conditions
- COVID-19
- Being tested
- GST-HG171, placebo of GST-HG171
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG171Drug
This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.
placebo of GST-HG171Drug
This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated.
| Study group | Role | What they receive |
|---|---|---|
| Single-dose ascending group | Experimental | SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 6 subjects receive study drug. Receives: Drug: GST-HG171 |
| SAD placebo comparator group | Placebo comparator | SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 2 subjects receive placebo. Receives: Drug: placebo of GST-HG171 |
| Multi-dose ascending group | Experimental | MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 6 subjects receive study drug. Receives: Drug: GST-HG171 |
| MAD placebo comparator group | Placebo comparator | MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive placebo. Receives: Drug: placebo of GST-HG171 |
| Food effect study | Experimental | FE study cotains at least 1 cohort which were evaluated in SAD study to be tolerated . Each cohort enrolls 12 subjects receive study drug on fast or fed condition. Receives: Drug: GST-HG171 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measured: SAD up to Day 5 and MAD up to Day 9
Secondary outcomes (6)
Peak Plasma Concentration (Cmax)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Area Under Curve (AUC)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
T1/2
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Cl/F
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Ae(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Fe(0~120h)
Plasma samples were collected at different points for pharmacokinetic analysis
Measured: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2022
- Study start1 Oct 2022
- Primary completion2 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668897
- Sponsor's protocol ID
- GST-HG171-I-01
- Status last verified
- Dec 2022
- First submitted
- 16 Dec 2022
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang H, Zhou J, Chen H, Mao J, Tang Y, Yan W, Zhang T, Li C, Chen S, Li G, Zhang G, Ding Y, Liu L. Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0111523. doi: 10.1128/aac.01115-23. Epub 2023 Dec 15.
PubMed 38099673
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose Ascending Phase Ia Clinical Trials in Healthy Subjects To Evaluate the Safety, Tolerability and Pharmacokinetics of GST-HG171 Tablets
- ClinicalTrials.gov ID
- NCT05668897
- Acronym / sponsor ID
- GST-HG171-I-01
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 30 Dec 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 and Pharmacokinetics on GST-HG171 Tablets in Randomized, Double-blind, Placebo-controlled Single-dose and Multiple-dose ascending Phase Ia Clinical Trials in Healthy Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Single-dose ascending group | Experimental | Drug: GST-HG171SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 6 subjects receive study drug. |
| SAD placebo comparator group | Placebo comparator | Drug: placebo of GST-HG171SAD study cotains at least 4 cohorts at dosage of 150mg, 300mg, 600mg and 900mg. Each cohort enrolls 2 subjects receive placebo. |
| Multi-dose ascending group | Experimental | Drug: GST-HG171MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 6 subjects receive study drug. |
| MAD placebo comparator group | Placebo comparator | Drug: placebo of GST-HG171MAD study cotains 1-3 cohorts which were evaluated in SAD study to be tolerated . Each cohort enrolls 2 subjects receive placebo. |
| Food effect study | Experimental | Drug: GST-HG171FE study cotains at least 1 cohort which were evaluated in SAD study to be tolerated . Each cohort enrolls 12 subjects receive study drug on fast or fed condition. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Sign the informed consent before the trial and fully understand the content, process and possible adverse reactions of the trial;
- Ability to complete research in accordance with test plan requirements;
- 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 50 years (including 18 and 50 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 18 ~ 28 kg / m2 (including critical value);
Key exclusion criteria (20 listed)
- Allergies (multiple drugs and food allergies);
- Those who smoked more than 5 cigarettes per day in the 3 months before the trial;
- 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);
- Blood donation or massive blood loss (> 400 mL) within three months before screening;
- Have a history of dysphagia or any gastrointestinal disease that affects drug absorption, including a history of frequent nausea or vomiting caused by any cause;
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-HG171This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated. | Drug | Food effect study, Multi-dose ascending group, Single-dose ascending group |
| placebo of GST-HG171This study includes single-dose ascending and multiple-dose ascending studies. SAD study contains at least 4 dose groups of 150 mg, 300 mg, 600 mg and 900 mg. MAD study contains 1-3 dose groups which were evaluated in SAD study to be tolerated. | Drug | MAD placebo comparator group, SAD placebo comparator group |
Primary outcome
safety and tolerability
Time frame: SAD up to Day 5 and MAD up to Day 9
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
6 secondary outcomes
Peak Plasma Concentration (Cmax)
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Area Under Curve (AUC)
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
T1/2
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Cl/F
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Ae(0~120h)
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Fe(0~120h)
Time frame: Measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96hours in single-dosing. In the multiple dose group, measured on -0.5, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12hours on Day1, more details in protocol.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Derived from this study: PubMed 38099673Zhang H, Zhou J, Chen H, Mao J, Tang Y, Yan W, Zhang T, Li C, Chen S, Li G, Zhang G, Ding Y, Liu L. Phase I study, and dosing regimen selection for a pivotal COVID-19 trial of GST-HG171. Antimicrob Agents Chemother. 2024 Jan 10;68(1):e0111523. doi: 10.1128/aac.01115-23. Epub 2023 Dec 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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-HG171 in people with COVID-19, run by Fujian Akeylink Biotechnology 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 12 Oct 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability (time frame: SAD up to Day 5 and MAD up to Day 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05668897, which also lists 1 linked publication.
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 12 Oct 2023.