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

NCT ID: NCT06385158

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-03
• Study Completion Date: 2024-11-05

Brief Summary

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

Detailed 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.

Conditions

Vasomotor System; Labile; Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GS1-144 tablet

Group Type: EXPERIMENTAL

GS1-144 tablet

Intervention Type: DRUG

GS1-144 tablet is an NK3R antagonist.

placebo controlled study

Group Type: PLACEBO_COMPARATOR

GS1-144 tablet

Intervention Type: DRUG

GS1-144 tablet is an NK3R antagonist.

Interventions

GS1-144 tablet

GS1-144 tablet is an NK3R antagonist.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

GenSci074-101

Identifier Type: -

Identifier Source: org_study_id