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A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Dose Escalation of GS1-144 Tablets and the Effects of Food on the Pharmacokinetics of GS1-144 in a Chinese Population

Recruiting
18 - 65 years of age
Both
Phase 1

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Overview

A Phase I clinical study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral dose escalation of GS1-144 tablets and the effects of food on the pharmacokinetics of GS1-144 in a Chinese population

Description

The primary purpose of this study is to assess the safety and tolerability of single ascending doses of GS1-144 in healthy participants in Part 1 and assessing the food effect in Part 2,and to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 3.

Eligibility

Inclusion Criteria:

At the time of signing the informed consent form (ICF):

        Part 1and Part 2 only: healthy male and female subjects aged between 18 and 45 years
        inclusive; Part 3 only: healthy women aged between 40 and 65 years inclusive who have
        undergone natural menopause (natural menopause is defined as surgically sterile
        (hysterectomy, bilateral salpingectomy, tubal ligation or bilateral oophorectomy - verbal
        confirmation through medical history review acceptable) or postmenopausal (no menses for 12
        months and confirmed by FSH level ≥40 mlU/mL);
          -  Body weight ≥ 50 kg (male), ≥ 45 kg (female) with a body mass index between 19.0 and
             27.9 kg/m2 inclusive at screening
          -  From signing the ICF to 1 month (female subjects) /3 months (male subjects and their
             female partners) after the end of the study, no family planning and egg/sperm donation
             plans, and effective contraceptive methods (such as IUD, bilateral tubal/vasectomy,
             condom and safe period calculation, etc.) (applicable to Parts 1 and 2)' ' ● Volunteer
             to sign ICF and be able to understand and comply with the requirements of this study
        Exclusion Criteria:
        Any known allergy to the components or analogues of the investigational product, or those
        with an allergic constitution (such as allergy to two or more drugs or foods);
          -  A history of currently suffering from any other cardiovascular, gastrointestinal,
             endocrine, hematological, hepatic, immunological, metabolic, urinary, pulmonary,
             neurological, dermatological, psychiatric, renal and/or other major diseases deemed
             clinically significant by the investigator;
          -  Known/confirmed history of malignancy;
          -  A history of epileptic seizure or increased risk of epileptic seizure, or subjects
             with a recent history (within six months prior to screening) of head trauma leading to
             loss of consciousness or concussion;
          -  A history of currently suffering from hypothalamic dysfunction;
          -  Significant acute/chronic infections within two weeks prior to dosing;
          -  Undergone major surgical procedures (such as coronary artery bypass grafting, organ
             resection, gynecological surgery, etc.) within six months prior to screening or plan
             to undergo any surgery during the trial;
          -  Participated in other clinical trials (except those who have not received any
             intervention) within 3 months prior to dosing, Or are participating in other clinical
             trials.
          -  Have lost or donated more than 400 mL of blood within 3 months prior to screening;
          -  Have taken any prescription/over-the-counter drugs or dietary supplements ,within 7
             days prior to dosing or within 5 half-lives of the drug (whichever is longer);
          -  Clinically significant abnormalities on physical examination or genitourinary
             ultrasound at the time of screening;
          -  Clinically significant abnormalities in vital signs, where the criteria for clinically
             significant blood pressure abnormalities are defined as systolic blood pressure ≥ 140
             mmHg or < 90 mmHg, and diastolic blood pressure ≥ 90 mmHg or < 60 mmHg;
          -  Prolonged QTcF interval in 12-lead ECG results (> 450 ms for males, > 470 ms for
             females) or clinically significant abnormalities in other 12-lead ECG parameters at
             screening;
          -  Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase
             (ALP), gamma-glutamyltransferase (GGT), total bilirubin (TBIL), blood creatinine
             (CRE), blood urea nitrogen (BUN), or international normalized ratio (INR) higher than
             the upper limit of normal (ULN) at screening, that are considered as clinically
             significant abnormalities by the investigator;
          -  Part 3 only: abnormal sex hormone levels at screening that are considered clinically
             significant by the investigator;
          -  Clinically significant abnormalities in thyroid function, parathyroid function, and
             neck ultrasound results at screening;
          -  Women with positive pregnancy test result or those who are breastfeeding before
             dosing;
          -  Positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus
             antibody (HIV Ab) or positive hepatitis B surface antigen (HbsAg) result at screening;
          -  Unable to refrain from consuming grapefruit, pomelo, grapefruit juice, or pomelo juice
             from 7 days prior to dosing until the end of the study;
          -  Unable to refrain from consuming any foods or beverages containing caffeine or
             xanthine (such as coffee, strong tea, chocolate, etc.) from 7 days prior to dosing
             until the end of the study;
          -  Unable to abstain from smoking/using tobacco products from 7 days prior to dosing
             until the end of the study, or positive urine cotinine test result before dosing
          -  Unable to refrain from consuming alcohol from 7 days prior to dosing until the end of
             the study, or positive breath alcohol test result before dosing;
          -  Any history of narcotic use or drug abuse, or positive urine drug screening result
             before dosing;
          -  Any medical or other condition, in the opinion of the investigator, may affect the
             clinical trial.

Study details

Vasomotor System; Labile, Healthy Volunteer

NCT06385158

Changchun GeneScience Pharmaceutical Co., Ltd.

29 April 2024

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