A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers

NCT06204250 | Completed Phase 1

• 1 other identifier: GenSci074-102
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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 to assess the safety and tolerability of multiple ascending doses of GS1-144 in healthy postmenopausal female participants in Part 2.

Conditions

Vasomotor Symptoms; Adult Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

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

  Number of participants with TEAEs and SAEs will be reported.

  Up to Day 4

• Part 2:Number of Participants With TEAEs and SAEs

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

  Up to Day 12

Secondary Outcomes (15)

• Parts 1 and 2: 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 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose

• Parts 1 and 2: 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 24 hour post-dose; Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose

• Parts 1 and 2: Cmax- Maximum Observed Plasma Concentration 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

• Parts 1 and 2: 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

• Parts 1 and 2: T1/2- Terminal Half-life 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

Study Arms (2)

Part 1 Single Ascending Dose: Cohorts 1 to 6

EXPERIMENTAL

Participants will receive GS1-144 5 mg, 15 mg, 30 mg, 60 mg , 90 mg and 120mg tablets once on Day 1 in their respective Cohort in Part 1. 2 participants will receive placebo in each cohort.

Drug: GS1-144; Drug: Placebo

Part 2 Multiple Ascending Dose: Cohorts 1 to 4

EXPERIMENTAL

tablets once on Day 1 in their respective Cohort in Part 2. 2 participants will receive placebo in each cohort.

Drug: GS1-144; Drug: Placebo

Interventions

GS1-144 DRUG

Oral tablets.

Part 1 Single Ascending Dose: Cohorts 1 to 6; Part 2 Multiple Ascending Dose: Cohorts 1 to 4

Placebo DRUG

Matching placebo tablets.

Part 1 Single Ascending Dose: Cohorts 1 to 6; Part 2 Multiple Ascending Dose: Cohorts 1 to 4

Eligibility Criteria

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

You may qualify if:

• At the time of signing the informed consent form (ICF): Part 1 only: healthy male and female participants aged between 18 and 45 years inclusive; Part 2 only: healthy women aged between 40 and 65 years inclusive who have undergone natural menopause;
• Body weight \>=50 kilogram (kg) (male), \>=45 kg (female) with a body mass index between 18.0 and 32.0 kilogram per square meter (kg/m\^2) inclusive at screening;
• Part 1 only: Female participants are eligible to participate if they are not pregnant, not breastfeeding, and highly effective contraception includes placement of an intrauterine device or intrauterine system plus use of a condom;
• Part 1 only: Male participants must agree to practice true abstinence; be surgically sterilized; or agree to use a condom plus effective contraception for their female partner, if of childbearing potential, from screening and for at least 90 days after dosing and refrain from donating sperm during this period. These contraception requirements do not apply if the male participant is in an exclusively same sex relationship;
• Able to comprehend the nature of the study and any risks associated with participation and willing to cooperate and comply with protocol restrictions and requirements.

You may not qualify if:

• Any known allergy to the components or analogues of the investigational product, or those with an allergic constitution;
• 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 participants with a recent history 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 within six months prior to screening or plan to undergo any surgery during the trial;
• Participated in other clinical trials within 1 month prior to dosing;
• Have lost or donated more than 400 mL of blood within 1 month prior to screening;
• Have taken any prescription/over-the-counter drugs or dietary supplements within 7 days prior to dosing or within 5 halflives of the drug;
• Clinically significant abnormalities on physical examination or genitourinary ultrasound at the time of screening;
• Clinically significant abnormalities in vital signs;
• Prolonged QTcF interval in 12-lead ECG results ;
• 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 2 only: abnormal sex hormone levels at screening that are considered clinically significant by the investigator;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead
• Syneos Health: collaborator

Study Sites (1)

Linear Clinical Research

Perth, Western Australia, WA 6027, Australia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: February 27, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

AU (1)