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

Last updated: February 14, 2025
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

GS1-144

Placebo

Clinical Study ID

NCT06204250
GenSci074-102
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. At the time of signing the informed consent form (ICF): Part 1 only: healthy maleand female participants aged between 18 and 45 years inclusive; Part 2 only: healthywomen aged between 40 and 65 years inclusive who have undergone natural menopause;

  2. Body weight >=50 kilogram (kg) (male), >=45 kg (female) with a body mass indexbetween 18.0 and 32.0 kilogram per square meter (kg/m^2) inclusive at screening;

  3. Part 1 only: Female participants are eligible to participate if they are notpregnant, not breastfeeding, and highly effective contraception includes placementof an intrauterine device or intrauterine system plus use of a condom;

  4. Part 1 only: Male participants must agree to practice true abstinence; be surgicallysterilized; or agree to use a condom plus effective contraception for their femalepartner, if of childbearing potential, from screening and for at least 90 days afterdosing and refrain from donating sperm during this period. These contraceptionrequirements do not apply if the male participant is in an exclusively same sexrelationship;

  5. Able to comprehend the nature of the study and any risks associated withparticipation and willing to cooperate and comply with protocol restrictions andrequirements.

Exclusion

Exclusion Criteria:

  1. Any known allergy to the components or analogues of the investigational product, orthose with an allergic constitution;

  2. 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 deemedclinically significant by the investigator;

  3. Known/confirmed history of malignancy;

  4. A history of epileptic seizure or increased risk of epileptic seizure, orparticipants with a recent history of head trauma leading to loss of consciousnessor concussion;

  5. A history of currently suffering from hypothalamic dysfunction;

  6. Significant acute/chronic infections within two weeks prior to dosing;

  7. Undergone major surgical procedures within six months prior to screening or plan toundergo any surgery during the trial;

  8. Participated in other clinical trials within 1 month prior to dosing;

  9. Have lost or donated more than 400 mL of blood within 1 month prior to screening;

  10. Have taken any prescription/over-the-counter drugs or dietary supplements within 7days prior to dosing or within 5 halflives of the drug;

  11. Clinically significant abnormalities on physical examination or genitourinaryultrasound at the time of screening;

  12. Clinically significant abnormalities in vital signs;

  13. Prolonged QTcF interval in 12-lead ECG results ;

  14. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkalinephosphatase (ALP), gamma-glutamyltransferase (GGT), total bilirubin (TBIL), bloodcreatinine (CRE), blood urea nitrogen (BUN), or international normalized ratio (INR)higher than the upper limit of normal (ULN) at screening, that are considered asclinically significant abnormalities by the investigator;

  15. Part 2 only: abnormal sex hormone levels at screening that are considered clinicallysignificant by the investigator;

  16. Clinically significant abnormalities in thyroid function, parathyroid function, andneck ultrasound results at screening;

  17. Women with positive pregnancy test result or those who are breastfeeding beforedosing;

  18. Positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virusantibody (HIV Ab) or positive hepatitis B surface antigen (HbsAg) result atscreening;

  19. Unable to refrain from consuming grapefruit, pomelo, grapefruit juice, or pomelojuice from 48 hours prior to check-in until the end of the study;

  20. Unable to refrain from consuming any foods or beverages containing caffeine orxanthine from 48 hours prior to check-in until the end of the study;

  21. Unable to abstain from smoking/using tobacco products from 48 hours prior tocheck-in until the end of the study;

  22. Unable to refrain from consuming alcohol from 48 hours prior to check-in until theend of the study;

  23. Any history of narcotic use or drug abuse;

  24. Any medical or other condition may affect the clinical trial.

Study Design

Total Participants: 86
Treatment Group(s): 2
Primary Treatment: GS1-144
Phase: 1
Study Start date:
February 27, 2024
Estimated Completion Date:
December 19, 2024

Study Description

This study will be divided into two sequential parts: Part 1 single ascending dose (SAD), and Part 2 multiple ascending dose (MAD) with the overall design.

Part 1 will enroll a total of approximately 46 healthy participants in five cohorts at 5 milligram (mg), 15 mg, 30 mg, 60 mg and 90 mg dose levels. Each cohort will have 2 participants receiving placebo. There is no restriction on the male-to female ratio.

Part 2 will be conducted after confirming the safety and tolerability of the ->30mg dose in Part 1 and will enroll a total of approximately 30 healthy postmenopausal female participants and provisionally consists of three cohorts at 15 mg, 30 mg 60 mg and 120mg dose levels. Each cohort will have 2 participants receiving placebo.

Connect with a study center

  • Linear Clinical Research

    Perth, Western Australia WA 6027
    Australia

    Site Not Available

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