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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06204250




Registration number
NCT06204250
Ethics application status
Date submitted
3/01/2024
Date registered
12/01/2024
Date last updated
25/03/2024

Titles & IDs
Public title
A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers
Scientific title
A Phase 1 Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets
Secondary ID [1] 0 0
GenSci074-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasomotor Symptoms 0 0
Adult Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS1-144
Treatment: Drugs - Placebo

Experimental: Part 1 Single Ascending Dose: Cohorts 1 to 5 - Participants will receive GS1-144 5 mg, 15 mg, 30 mg, 60 mg and 90 mg tablets once on Day 1 in their respective Cohort in Part 1. 2 participants will receive placebo in each cohort.

Experimental: Part 2 Multiple Ascending Dose: Cohorts 1 to 3 - Participants will receive GS1-144 15 mg, 30 mg and 60 mg tablets once on Day 1 in their respective Cohort in Part 2. 2 participants will receive placebo in each cohort.


Treatment: Drugs: GS1-144
Oral tablets.

Treatment: Drugs: Placebo
Matching placebo tablets.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Up to Day 4
Primary outcome [2] 0 0
Part 2:Number of Participants With TEAEs and SAEs
Timepoint [2] 0 0
Up to Day 12
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Parts 1 and 2: AUC0-infinity- Area Under the Drug Concentration-time Curve From 0 to Infinity for GS1-144
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Parts 1 and 2: Cmax- Maximum Observed Plasma Concentration for GS1-144
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Parts 1 and 2: Tmax- Time to Reach the Maximum Plasma Concentration (Cmax) for GS1-144
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Parts 1 and 2: T1/2- Terminal Half-life for GS1-144
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Parts 1 and 2: CL/F- Apparent Clearance for GS1-144
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Parts 1 and 2: Vd/F- Apparent Volume of Distribution for GS1-144
Timepoint [7] 0 0
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
Secondary outcome [8] 0 0
Part 2: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144
Timepoint [8] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [9] 0 0
Part 2: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144
Timepoint [9] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [10] 0 0
Part 2: Tmax,ss- Time of Cmax at Steady State for GS1-144
Timepoint [10] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [11] 0 0
Part 2: Cavg,ss- Average Concentration at Steady State for GS1-144
Timepoint [11] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [12] 0 0
Part 2: AUC0-t- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144
Timepoint [12] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [13] 0 0
Part 2: CLss/F- CL for Bioavailability at Steady State for GS1-144
Timepoint [13] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [14] 0 0
Part 2: T1/2,ss- Terminal Half-life at Steady State for GS1-144
Timepoint [14] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Secondary outcome [15] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Timepoint [15] 0 0
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose

Eligibility
Key inclusion criteria
1. 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;
2. 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;
3. 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;
4. 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;
5. 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any known allergy to the components or analogues of the investigational product, or those 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 deemed clinically significant by the investigator;
3. Known/confirmed history of malignancy;
4. 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;
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 to undergo 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 7 days prior to dosing or within 5 halflives of the drug;
11. Clinically significant abnormalities on physical examination or genitourinary ultrasound 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), 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;
15. Part 2 only: abnormal sex hormone levels at screening that are considered clinically significant by the investigator;
16. Clinically significant abnormalities in thyroid function, parathyroid function, and neck ultrasound results at screening;
17. Women with positive pregnancy test result or those who are breastfeeding before dosing;
18. Positive hepatitis C virus antibody (HCV Ab), positive human immunodeficiency virus antibody (HIV Ab) or positive hepatitis B surface antigen (HbsAg) result at screening;
19. 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;
20. 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;
21. Unable to abstain from smoking/using tobacco products from 48 hours prior to check-in until the end of the study;
22. Unable to refrain from consuming alcohol from 48 hours prior to check-in until the end 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
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/12/2024
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research - Perth
Recruitment postcode(s) [1] 0 0
WA 6027 - Perth

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Changchun GeneScience Pharmaceutical Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06204250
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Fanny Hou
Address 0 0
Country 0 0
Phone 0 0
8618502191682
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06204250