Status:
COMPLETED
A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers
Lead Sponsor:
Changchun GeneScience Pharmaceutical Co., Ltd.
Collaborating Sponsors:
Syneos Health
Conditions:
Vasomotor Symptoms
Adult Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 ...
Detailed 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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- 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 48 hours prior to check-in until the end of the study;
- Unable to refrain from consuming any foods or beverages containing caffeine or xanthine from 48 hours prior to check-in until the end of the study;
- Unable to abstain from smoking/using tobacco products from 48 hours prior to check-in until the end of the study;
- Unable to refrain from consuming alcohol from 48 hours prior to check-in until the end of the study;
- Any history of narcotic use or drug abuse;
- Any medical or other condition may affect the clinical trial.
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT06204250
Start Date
February 27 2024
End Date
December 19 2024
Last Update
February 17 2025
Active Locations (1)
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1
Linear Clinical Research
Perth, Western Australia, Australia, WA 6027