GS1-144 in Participants With Hepatic Impairment and Healthy Female

NCT07491289 | Not Yet Recruiting Phase 1

• 1 other identifier: GenSci074-105
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

GS1-144 in Participants with Hepatic Impairment and Healthy Female

Conditions

Hepatic Impairment and Healthy Female

Outcome Measures

Primary Outcomes (6)

• Maximum concentration (Cmax) of GS1-144 Cmax will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• Area under the curve from time 0 to the last time with quantifiable concentration (AUC0-t ) of GS1-144 AUC0-t will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• Area under the curve from time 0 to infinity (AUC0-∞) of GS1-144 AUC0-∞ will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• Time to maximum concentration (Tmax) of GS1-144 Tmax will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• elimination half-life (t1/2) of GS1-144 t1/2 will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• apparent clearance (CL/F) of GS1-144 CL/F will be assessed and reported.

  From time of taking the GS1-144 up to day 4

Secondary Outcomes (10)

• Apparent volume of distribution (Vz/F) of GS1-144 Vz/F will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• Cmax of metabolite M1. Cmax of metabolite M1 will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• AUC0-t of metabolite M1. AUC0-t of metabolite M1 will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• AUC0-∞ of metabolite M1. AUC0-∞ of metabolite M1 will be assessed and reported.

  From time of taking the GS1-144 up to day 4

• Tmax of metabolite M1. Tmax of metabolite M1 will be assessed and reported.

  From time of taking the GS1-144 up to day 4

Study Arms (1)

GS1-144 tablet

EXPERIMENTAL

Drug: GS1-144 tablet

Interventions

GS1-144 tablet DRUG

Administered a single oral dose with GS1-144 tablet 30mg

GS1-144 tablet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who sign the ICF prior to the trial, have a full understanding of the trial content, procedures, and possible adverse reactions, and are able to complete the study in accordance with the protocol requirements。
• Female participants aged 18-70 years (inclusive) (age-matched between the normal hepatic function group and the hepatic impairment groups, mean ±10 years).
• Females of childbearing potential who are willing to use adequate and effective contraception from the date of signing the ICF until 1 month after administration of the investigational drug.
• Body weight ≥ 45.0 kg (body weight matched between the normal hepatic function group and the hepatic impairment groups, mean body weight ±10 kg), with BMI within 18.0-32.0 kg/m2 (inclusive).
• For participants with normal hepatic function, findings from physical examination, vital signs, clinical laboratory tests (hematology, blood chemistry, urinalysis, coagulation tests, thyroid function test \[FT3, FT4, and TSH\], and parathyroid hormone), Chest x-ray (PA), abdominal ultrasound examinations, etc., are normal or abnormal without clinical significance.
• Hepatic impairment caused by hepatitis B, hepatitis C, autoimmune hepatitis, nonalcoholic fatty liver disease, alcoholic liver disease, etc., with Child-Pugh classification assessed as Class A/mild (Child-Pugh score: 5-6) or Class B/moderate (Child-Pugh score: 7-9)
• A stable medication regimen for the treatment of hepatic impairment, complications, and/or other concomitant diseases for at least 14 days prior to screening, with no need for modification (e.g., medication type, dose, or dosing frequency); or not receiving medication.
• Clinical laboratory tests: absolute neutrophil count (ANC) ≥ 1.0 × 109/L (1,000/mm3), platelets (PLT) ≥ 35.0 × 109/L (35,000/mm3), hemoglobin (HGB) ≥ 8.0 g/dL (80 g/L), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 5 times the upper limit of normal (ULN), creatinine clearance (CLcr, calculated using the Cockcroft-Gault formula) ≥ 60 mL/min.
• Systolic blood pressure 90-159 mmHg (Inclusive), diastolic blood pressure 60-99 mmHg (inclusive), and pulse rate 50-100 beats per minute (bpm, inclusive).

You may not qualify if:

• Allergic constitution (e.g., allergy to more than two drugs or foods), or a history of allergy to the investigational drug or any excipients thereof.
• Use of tobacco-containing products, nicotine, or nicotine-containing products (e.g., e-cigarettes) within 1 month prior to screening, or unwillingness to stop smoking during the study.
• Alcohol abuse within 3 months prior to screening (weekly consumption ≥ 14 units of alcohol: 1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or unwillingness to stop drinking during the study.
• Blood loss or donation of ≥ 450 mL of whole blood or plasma within 3 months prior to screening, or receipt of any transfusion of blood or blood products within 60 days.
• Use of CYP1A2 inducers or CYP1A2 inhibitors within 1 month or within 5 half-lives prior to screening (whichever is longer), and throughout the study (except stable concomitant medications for participants with hepatic impairment).
• Use of any of the following drugs within 1 month or within 5 half-lives prior to screening (whichever is longer) (including vitamins, hormonal contraceptives, hormone replacement therapy \[HRT\], and traditional Chinese medicines, herbal medicines, and Chinese patent medicines \[e.g., St. John's wort\]), except for occasional use of acetaminophen (≤ 2 g/day), topical dermatologic medications (including corticosteroids), and stable concomitant medications for participants with hepatic impairment.
• Clinically significant abnormal 12-lead ECG findings \[e.g., tachycardia/bradycardia requiring drug treatment, second- to third-degree atrioventricular block, or QTcF \> 470 ms (corrected by Fridericia's formula), or other clinically significant abnormalities\], and deemed by the investigator as unsuitable for participation.
• Participation in any clinical study within 3 months or within 5 half-lives prior to screening (whichever is longer) (except those who did not receive treatment).
• Severe infection, trauma, gastrointestinal surgery, portosystemic shunt, or other major surgeries within 4 weeks prior to screening.
• Pregnancy, lactation, or a positive serum pregnancy test.
• Consumption of excessive amounts of tea, coffee, or caffeinated beverages (≥8 cups per day; 1 cup = 250 mL) within 3 months prior to screening; or intake of any food or beverage containing caffeine or xanthine, or that may produce caffeine or xanthine metabolites after ingestion (e.g., coffee, tea, chocolate, cola) within 1 day prior to dosing.
• Positive urine drug screening (including morphine, methamphetamine, ketamine, 3,4-methylenedioxymethamphetamine \[MDMA\], tetrahydrocannabinolic acid, or cocaine). Positive alcohol breath test.
• Any other condition deemed by the investigator to make the participant unsuitable for participation in this study.
• Participants with normal hepatic function with a history or current serious disease of the gastrointestinal, respiratory, renal, neurologic, hematologic, endocrine, immune, psychiatric, or cardio-cerebrovascular systems.
• Participants with normal hepatic function who test positive for any of the following: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab), human immunodeficiency virus antibody (HIV Ab), or TP Ab.

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

Central Study Contacts

Hong Zhang

CONTACT

+86 18186870853; jhongzhang@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CN (1)