Clinical Trials/NCT06385158

NCT06385158

Completed

Phase 1

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

Changchun GeneScience Pharmaceutical Co., Ltd.1 site in 1 country110 target enrollmentJanuary 3, 2024

ConditionsVasomotor System; Labile Healthy Volunteer

InterventionsGS1-144 tablet

DrugsGS1-144 tablet

Overview

Phase: Phase 1
Intervention: GS1-144 tablet
Conditions: Vasomotor System; Labile
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Enrollment: 110
Locations: 1
Primary Endpoint: Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 3, 2024

End Date

November 5, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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);

Arms & Interventions

GS1-144 tablet

Intervention: GS1-144 tablet

placebo controlled study

Intervention: GS1-144 tablet

Outcomes

Primary Outcomes

Part 1:Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time Frame: Up to Day 4

Number of participants with TEAEs and SAEs will be reported

Part 2: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs).

Time Frame: Up to Day 9;

Number of participants with TEAEs and SAEs will be reported.

Part 3: Number of Participants With TEAEs and SAEs

Time Frame: Up to Day 12

Number of female post-menopausal participants with TEAEs and SAEs will be reported.

Secondary Outcomes

Part 1 , Part2 and Part 3: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144(Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,)
Part1,Part2 and Part3 AUC0-t- Area Under the Drug Concentration-time Curve From Time 0 to the Last Sample Collection Time t for GS1-144(Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,)
Part 1, Part2 and Part 3: Cmax- Maximum Observed Plasma Concentration for GS1-144(Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose,)
Part 1 Part2 and Part 3: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144(Part 1 Day 1- pre-dose and up to 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose)
Part 1 Part2 and Part 3:: T1/2- Terminal Half-life for GS1-144(Time Frame: Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 1 Part2 and Part 3: CL/F- Apparent Clearance for GS1-144(Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 1 Part2 and Part 3: Vd/F- Apparent Volume of Distribution for GS1-144(Part 1 Day 1- pre-dose and up to 72 hour post-dose; Part 2 Days 1 and 6-pre-dose and up to 72 hour post-dose, Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: Tmax,ss- Time of Cmax at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: Cavg,ss- Average Concentration at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: CLss/F- CL for Bioavailability at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 30 hour post-dose)
Part 3: T1/2,ss- Terminal Half-life at Steady State for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 3: Accumulation Ratio for GS1-144(Part 3 Days 1 and 7-pre-dose and up to 72 hour post-dose)
Part 1: Baseline and placebo-adjusted changes in ∆∆QTc and other ECG parameters after oral administration of GF1-144 in healthy subjects(Part 1 Day 1- pre-dose and up to 24 hour post-dose)