Vasomotor SymptomsPhase 1NCT06204250
A Study to Assess Safety and Tolerability of GS1-144 in Healthy Volunteers
A Phase 1 study testing GS1-144 in people with Vasomotor Symptoms and Adult Healthy Volunteers, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Vasomotor Symptoms, Adult Healthy Volunteers
- What is being tested?
- GS1-144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteAustralia
- Study dates
- 27 Feb 2024to 19 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets
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.
Read the 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 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.
- Conditions
- Vasomotor Symptoms, Adult Healthy Volunteers
- Being tested
- GS1-144, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS1-144Drug
Oral tablets.
PlaceboDrug
Matching placebo tablets.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: GS1-144; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
AUC0-t will be assessed and reported.
Measured: 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
AUC0-infinity will be assessed and reported.
Measured: 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
Cmax will be assessed and reported.
Measured: 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
Tmax will be assessed and reported.
Measured: 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
T1/2 will be assessed and reported.
Measured: 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: CL/F- Apparent Clearance for GS1-144
CL/F will be assessed and reported.
Measured: 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: Vd/F- Apparent Volume of Distribution for GS1-144
Vd/F will be assessed and reported.
Measured: 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 2: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144
Cmax at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144
Cmin at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Tmax,ss- Time of Cmax at Steady State for GS1-144
Tmax at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Cavg,ss- Average Concentration at Steady State for GS1-144
Cavg at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144
AUC0-T at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: CLss/F- CL for Bioavailability at Steady State for GS1-144
CL/F at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: T1/2,ss- Terminal Half-life at Steady State for GS1-144
T1/2 at steady state will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Accumulation Ratio will be assessed and reported.
Measured: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start27 Feb 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vasomotor SymptomsStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06204250
- Sponsor's protocol ID
- GenSci074-102
- Status last verified
- Feb 2025
- First submitted
- 3 Jan 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of GS1-144 Tablets
- ClinicalTrials.gov ID
- NCT06204250
- Acronym / sponsor ID
- GenSci074-102
- Conditions
- Vasomotor Symptoms, Adult Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 27 Feb 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Single Ascending Dose: Cohorts 1 to 6 | Experimental | Drug: GS1-144, Drug: PlaceboParticipants 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. |
| Part 2 Multiple Ascending Dose: Cohorts 1 to 4 | Experimental | Drug: GS1-144, Drug: Placebotablets once on Day 1 in their respective Cohort in Part 2. 2 participants will receive placebo in each cohort. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS1-144Oral tablets. | Drug | Part 1 Single Ascending Dose: Cohorts 1 to 6, Part 2 Multiple Ascending Dose: Cohorts 1 to 4 |
| PlaceboMatching placebo tablets. | Drug | Part 1 Single Ascending Dose: Cohorts 1 to 6, Part 2 Multiple Ascending Dose: Cohorts 1 to 4 |
Primary outcome
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 TEAEs and SAEs
Time frame: Up to Day 12
Number of female post-menopausal participants with TEAEs and SAEs will be reported.
15 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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: CL/F- Apparent Clearance for GS1-144
Time frame: 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: Vd/F- Apparent Volume of Distribution for GS1-144
Time frame: 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 2: Cmax,ss- Observed Maximum Concentration at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Cmin,ss- Observed Minimum Concentration at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Tmax,ss- Time of Cmax at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: Cavg,ss- Average Concentration at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: AUC0-τ- Area Under the Drug Concentration-time Curve During the Dosing Interval at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: CLss/F- CL for Bioavailability at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2: T1/2,ss- Terminal Half-life at Steady State for GS1-144
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Time frame: Part 2 Days 1 and 7-pre-dose and up to 30 hour post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS1-144 in people with Vasomotor Symptoms and Adult Healthy Volunteers, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Participants With Treatment -Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.