COVID-19 PneumoniaPhase 1NCT06106113
Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function
A Phase 1 study testing GST-HG171 Tablets in people with COVID-19 Pneumonia, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pneumonia
- What is being tested?
- GST-HG171 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2022to 30 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All subjects are required to meet all of the following conditions
- Voluntarily sign informed consent prior to the start of activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol to complete this study;
- Subjects (including their partners) are willing to have no family planning and voluntarily take highly effective contraception within 6 months after the last study drug administration;
- Age range from 18 to 65 (including both ends) on the date of signing the informed consent, both male and female;
- Male subjects should weigh no less than 50 kg and female subjects should weigh no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
- Creatinine clearance (calculated by Cockcroft-Gault formula) ≥60 mL/min;
Show all 15Show fewer
- Subjects with normal liver function should also meet all of the following conditions:
- The following demographic matching criteria must be met during screening:
- Body weight was matched with that of the group with liver function impairment, with an average of ±10 kg;
- Age matching was performed between the group with liver function impairment, the mean was ±10 years old;
- Gender matching was performed with liver function impairment group, and the mean was ±1 case;
- Subjects with impaired liver function should also meet all of the following conditions:
- Chronic liver injury caused by primary liver diseases (such as hepatitis B, hepatitis C, autoimmune hepatitis, alcoholic liver disease, etc.), liver insufficiency patients with Child-Pugh grade A or B;
- Cirrhosis was clinically diagnosed;
- Stable medication regimen for liver dysfunction, complications and other concomitant diseases for at least 14 days prior to taking the study drug, and no adjustment of medication (including type, dosage or frequency of medication) is required; Or have not used drugs;
Who cannot join
- Subjects meeting any of the following exclusion criteria will not be enrolled in this study
- Allergic constitution, including severe drug allergy or history of drug allergy, known allergy to the study drug or any component of the study drug;
- During the screening period, electrocardiogram showed QTc interphase (QTcF) >470 msec for males and >480 msec for females (corrected according to Fridericia's standard);
- A history of dysphagia or any gastrointestinal disorder affecting drug absorption, including frequent nausea or vomiting due to any etiology;
- Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
- Those who had been vaccinated within 14 days prior to screening or planned to be vaccinated during the study period;
Show all 27Show fewer
- Those who donated blood or lost more than 200 mL of blood within 3 months prior to screening, or intended to donate blood during the trial or within 1 month after the trial;
- A strong or medium acting inducer or inhibitor of CYP3A enzyme, a strong P-glycoprotein (P-gp) inhibitor or inducer used within 1 month before screening;
- D1 had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice and/or caffeinated beverages (more than 8 cups of 200 mL per cup per day on average) in the 2 weeks prior to administration;
- Binge drinkers in the 3 months preceding screening, i.e. those who consume more than 14 units of alcohol per week (1 unit = 360 mL beer, or 45 mL spirits with 40% alcohol by volume, or 150 mL wine) or those who test positive for alcohol; Smokers who smoked at least 10 cigarettes a day in the 3 months before screening;
- Those who have a history of drug use, or drug abuse, or test positive for drug abuse;
- Pregnant or lactating women or women of childbearing age who have tested positive for pregnancy;
- Patients who cannot tolerate venipunction or have a history of fainting needle and fainting blood;
- Those not suitable for inclusion for other reasons;
- Subjects with normal liver function should be excluded if they meet any of the following exclusion criteria:
- History of liver injury;
- Have been or are currently suffering from any clinically serious disease such as circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatric and metabolic abnormalities, or any other disease that may interfere with the test results;
- Physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal color ultrasound and other abnormalities were judged by researchers to have clinical significance;
- Hepatitis B surface antigen, hepatitis C antibody or hepatitis C core antigen, HIV antigen/antibody or syphilis antibody positive for any index;
- Study the use of any prescription, over-the-counter, Chinese herbal or supplement within 14 days prior to drug administration;
- Use of other clinical trial drugs within 3 months prior to screening or plan to participate in other clinical trials.
- Subjects with liver function impairment who meet any of the following exclusion criteria shall be excluded:
- The subject has any of the following conditions: drug-induced liver injury; History of liver transplantation; In addition, patients with cirrhosis that is considered to be complicated by the following complications, including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal varicose hemorrhage, etc.;
- The laboratory test results during screening were consistent with any of the following: (a) alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >10×ULN; (b) neutrophil absolute value (NE#) <0.75×109/L; (c) Hemoglobin (HGB) <60 g/L; (d) alpha-fetoprotein (AFP) >100 ng/mL;
- HIV antigen/antibody screening positive; If syphilis antibody is positive, rapid plasma rereaction hormone test (RPR) should be added. If RPR is positive at the same time, it should be excluded.
- In addition to the primary liver disease itself, those who have had or currently suffered from other serious systemic organ diseases, including but not limited to gastrointestinal, respiratory, kidney, nervous, blood, endocrine, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases, or abnormal clinical laboratory tests have clinical significance, and are judged by the study doctor to be unfit to participate in this study;
- Participants who used other clinical trials within 1 month prior to screening or planned to participate in other clinical trials during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function.
- Conditions
- COVID-19 Pneumonia
- Being tested
- GST-HG171 Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GST-HG171 TabletsDrug
150mg GST-HG171 Tablets
| Study group | Role | What they receive |
|---|---|---|
| Mild hepatic impairment | Other | 150 mg GST-HG171 Receives: Drug: GST-HG171 Tablets |
| Moderate hepatic impairment | Other | 150 mg GST-HG171 Receives: Drug: GST-HG171 Tablets |
| healthy subjects with normal hepatic function | Other | 150 mg GST-HG171 Receives: Drug: GST-HG171 Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) for GST-HG171
Maximum observed plasma GST-HG171 concentration.
Measured: Day 1 at 0 (pre-dose) ,0.25 ,0.5 ,0.75 ,1 ,1.25 ,1.5 ,2 ,3 ,4 ,6 ,8 ,12 ,24 and 48 hours post-dose
Secondary outcomes (1)
AEs
To evaluate the safety and tolerability of GST-HG171 tablets after a single oral administration in subjects with mild and moderate liver impairment and normal liver function
Measured: up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start15 Dec 2022
- Primary completion6 Feb 2023
- Study completion30 May 2023
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-19 PneumoniaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT06106113
- Sponsor's protocol ID
- GST-HG171-I-02
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou J, Zhang H, Chen H, Zhang G, Mao J, Zhang T, Tang Y, Yan W, Li C, Ding Y, Jin Q. Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0053924. doi: 10.1128/aac.00539-24. Epub 2024 Jul 11.
PubMed 38990016
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Liver Function
- ClinicalTrials.gov ID
- NCT06106113
- Acronym / sponsor ID
- GST-HG171-I-02
- Conditions
- COVID-19 Pneumonia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Fujian Akeylink Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 6 Feb 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 30 Oct 2023 (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.
This si a single-center, non-randomized, open, parallel, single-dose trial was designed to evaluate the safety and pharmacokinetic characteristics of GST-HG171 tablets in subjects with impaired liver function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild hepatic impairment | Other | Drug: GST-HG171 Tablets150 mg GST-HG171 |
| Moderate hepatic impairment | Other | Drug: GST-HG171 Tablets150 mg GST-HG171 |
| healthy subjects with normal hepatic function | Other | Drug: GST-HG171 Tablets150 mg GST-HG171 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- All subjects are required to meet all of the following conditions
- Voluntarily sign informed consent prior to the start of activities related to this study, be able to understand the procedures and methods of this study, and be willing to strictly follow the clinical trial protocol to complete this study;
- Subjects (including their partners) are willing to have no family planning and voluntarily take highly effective contraception within 6 months after the last study drug administration;
- Age range from 18 to 65 (including both ends) on the date of signing the informed consent, both male and female;
- Male subjects should weigh no less than 50 kg and female subjects should weigh no less than 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
Key exclusion criteria (27 listed)
- Subjects meeting any of the following exclusion criteria will not be enrolled in this study
- Allergic constitution, including severe drug allergy or history of drug allergy, known allergy to the study drug or any component of the study drug;
- During the screening period, electrocardiogram showed QTc interphase (QTcF) >470 msec for males and >480 msec for females (corrected according to Fridericia's standard);
- A history of dysphagia or any gastrointestinal disorder affecting drug absorption, including frequent nausea or vomiting due to any etiology;
- Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
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-HG171 Tablets150mg GST-HG171 Tablets | Drug | Mild hepatic impairment, Moderate hepatic impairment, healthy subjects with normal hepatic function |
Primary outcome
Maximum observed plasma concentration (Cmax) for GST-HG171
Time frame: Day 1 at 0 (pre-dose) ,0.25 ,0.5 ,0.75 ,1 ,1.25 ,1.5 ,2 ,3 ,4 ,6 ,8 ,12 ,24 and 48 hours post-dose
Maximum observed plasma GST-HG171 concentration.
1 secondary outcome
AEs
Time frame: up to Day 7
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 30 Oct 2023.
- Derived from this study: PubMed 38990016Zhou J, Zhang H, Chen H, Zhang G, Mao J, Zhang T, Tang Y, Yan W, Li C, Ding Y, Jin Q. Pharmacokinetics and safety of GST-HG171, a novel 3CL protease inhibitor, in Chinese subjects with impaired and normal liver function. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0053924. doi: 10.1128/aac.00539-24. Epub 2024 Jul 11.
Related trials for COVID-19 Pneumonia
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
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 Tablets in people with COVID-19 Pneumonia, 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 15 inclusion and 27 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 30 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. 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?
Maximum observed plasma concentration (Cmax) for GST-HG171 (time frame: Day 1 at 0 (pre-dose) ,0.25 ,0.5 ,0.75 ,1 ,1.25 ,1.5 ,2 ,3 ,4 ,6 ,8 ,12 ,24 and 48 hours post-dose). 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 NCT06106113, 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 30 Oct 2023.