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COVID-19 PneumoniaNCT06106126

Pharmacokinetics and Safety of GST-HG171 Tablets in Subjects With Impaired and Normal Renal Function

A study testing GST-HG171 Tablets in people with COVID-19 Pneumonia, run by Fujian Akeylink Biotechnology Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 renal function. Read more about this study

Who is it for?
Ages 18 to 70 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
32 participants
Where
1 siteChina
Study dates
10 Feb 2023to 1 Mar 2024
Phase
Interventional
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 70 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 70 (including both ends) on the date of signing the informed consent, both male and female;
  • Male subjects weigh at least 50 kg and female subjects weigh at least 45 kg; Body mass index (BMI) 18-32 kg/m2 (including both ends);
  • Subjects with normal renal function should also meet all of the following conditions:
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  • Physical examination, vital signs and electrocardiogram are normal or abnormal without clinical significance;
  • The glomerular filtration rate should meet the following criteria: Subjects with normal renal function: GFR≥90 mL/min;
  • The following demographic matching criteria must be met during screening:
  • The body weight was matched with that of the renal impairment group, with an average of ±10 kg;
  • Age matching was performed with the renal impairment group, with the mean ±10 years old;
  • Gender matching was performed with the group of renal impairment, with the mean ±1 case;
  • Subjects with renal impairment should also meet all of the following conditions:
  • Have chronic kidney disease (CKD), have any indicators of kidney injury or have a GFR less than 60 mL/min for more than 3 months (outpatient medical records, inpatient records or laboratory records can be used as evidence);
  • The glomerular filtration rate shall meet the following criteria: Subjects with mild renal impairment (stage CKD2) : 60-89 mL/min (including values at both ends), subjects with moderate renal impairment (stage CKD3) : 30-59 mL/min (including values at both ends), subjects with severe renal impairment (stage CKD4) : 15-29 mL/min (including both ends);
  • Renal function was stable, and GFR results of two tests before administration (at least 3 days apart) should be in the same CKD stage;
  • Except for renal dysfunction and complications, the investigator judged that the physical condition was good based on medical history inquiry, comprehensive physical examination, routine laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function, etc.), 12-lead electrocardiogram, chest X-ray (orthographic), abdominal B-ultrasound examination, etc.

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;
  • Those who donated blood ≥400 mL within 3 months before screening, or donated blood ≥200 mL within 1 month before screening, or received blood transfusion or used blood products;
  • Patients with severe infection, trauma, gastrointestinal surgery or other major surgical operations within 4 weeks before screening;
  • A history of difficulty swallowing or any gastrointestinal disorder affecting drug absorption, including frequent nausea or vomiting due to any etiology;
  • A strong or medium acting inducer or inhibitor of CYP3A enzyme, a strong P-gp inhibitor or P-gp inducer used within 1 month before screening;
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  • Those who had been vaccinated within 14 days prior to screening or planned to be vaccinated during the study period;
  • Smokers who smoked at least 10 cigarettes a day in the 3 months before screening;
  • had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or had 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;
  • A history of drug or substance abuse and/or alcoholism (14 units of alcohol per week: 1 unit = 285 mL for beer, 25 mL for spirits, or 100 mL for wine);
  • had taken any products containing alcohol or had tested positive for alcohol breath test within 24 hours before receiving the study drug;
  • Positive urine drug screening (morphine, cannabis);
  • Pregnant or lactating women or women of childbearing age who have tested positive for pregnancy;
  • Active HBV or HCV infection, HIV-positive, or treponema pallidum antibody positive and rapid plasma response (RPR) positive (RPR only for treponema pallidum antibody positive);
  • Those not suitable for inclusion for other reasons;
  • Subjects with normal renal function should be excluded if they meet any of the following exclusion criteria:
  • Participants who have participated in clinical trials of drugs or medical devices within 3 months prior to screening (subject to drug acceptance);
  • had taken any prescription drugs, over-the-counter drugs, any vitamin products or herbs in the 14 days prior to screening;
  • Abnormal clinical laboratory examination with clinical significance, or other clinically significant diseases (including but not limited to respiratory system, digestive system, urinary system, nervous system, blood system, endocrine system, tumor, immune, psychiatric or cardiovascular and cerebrovascular diseases) found by other clinical findings in the 12 months prior to screening;
  • Subjects with renal impairment should be excluded if they meet any of the following exclusion criteria:
  • Participants who have participated in clinical trials of drugs or medical devices within 1 month before screening (subject to drug acceptance);
  • Patients with acute renal failure or who have had a kidney transplant; Or require kidney dialysis during the study;
  • In addition to the chronic primary renal disease itself and its complications, those who have suffered from or currently suffer from other serious systemic organ diseases, including but not limited to digestive system, respiratory system, nervous system, blood system, endocrine system, tumor, immune system, psychiatric or cardiovascular and cerebrovascular diseases, and are judged by the study doctor as unfit to participate in this study;
  • hypertension that is not well controlled by antihypertensive medications (systolic blood pressure ≥150 mm Hg or diastolic blood pressure ≥100 mm Hg);
  • Laboratory examination: alanine aminotransferase (ALT) ≥2×ULN, aspartate aminotransferase (AST) ≥2×ULN; Serum total bilirubin >1.5×ULN; Albumin <30 g/L; Neutrophil absolute value <1.3×109/L; Hemoglobin <60g/L; Platelet count <100×109/L;
  • New York Heart Association (NYHA) Grade III or IV for congestive heart failure, or left ventricular ejection fraction <50% at screening.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The first hospital of Jilin University

    Changchun, Jilin, 130021

    Yanhua Ding, Dr., +86-18186879768, dingyanhua2003@126.com

    Junqi Ding, Dr., +86-13756661205, junqiniu@aliyun.com

    Recruiting

Other trials in China

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 renal function.

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 100mg Tablets and ritonavir

Study groups in NCT06106126
Study groupRoleWhat they receive
Mild renal impairmentOtherNot described
Receives: Drug: GST-HG171 Tablets
Moderate renal impairmentOtherNot described
Receives: Drug: GST-HG171 Tablets
Severe renal impairmentOtherNot described
Receives: Drug: GST-HG171 Tablets
Normal Renal FunctionOtherNot described
Receives: Drug: GST-HG171 Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed plasma concentration (Cmax) for GST-HG171

    Maximum observed plasma GST-HG171 concentration.

    Measured: Day 1 (predose), 0.25,0.5 ,0.75,1 ,1.25,1.5,2 ,3 ,4 ,6 ,8 ,12,24 ,48 and 72 hours post-dose

Secondary outcomes (1)

  1. AEs

    To evaluate the safety and tolerability of GST-HG171 tablets in subjects with impaired renal function.

    Measured: up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2023
  2. Study start10 Feb 2023
  3. Primary completion28 Feb 2024 (estimated)
  4. Study completion1 Mar 2024 (estimated)

Resources

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 N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06106126
Sponsor's protocol ID
GST-HG171-I-03
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
Individual data sharing
Undecided

Publications

  • Li Q, Wu M, Mao J, Zhang T, Yan W, Yan X, Li C, Zhang G, Ding Y, Mai J, Zhang H. Pharmacokinetics, safety, and dose optimization of GST-HG171 in renal impairment: insights from physiologically based pharmacokinetic modeling. Antimicrob Agents Chemother. 2026 Aug 5;70(8):e0154125. doi: 10.1128/aac.01541-25. Epub 2026 Jul 15.

    PubMed 42455066

Questions about this trial

What is this clinical trial studying?

A 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 17 inclusion and 26 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 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. 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 (predose), 0.25,0.5 ,0.75,1 ,1.25,1.5,2 ,3 ,4 ,6 ,8 ,12,24 ,48 and 72 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 NCT06106126, 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.

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