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The purpose of this study is to assess safety and tolerability of multiple oral doses of GSBR-1290 (capsule) in healthy adult Japanese participants compared to non-Japanese participants.
This is a multiple ascending dose (MAD) study in which 4 dose levels will be evaluated in 2 cohorts from Day 1 to Day 28 (4-week period). The starting dose of GSBR-1290 will be based on results from the single ascending dose (SAD) study (GSBR-1290-01) and MAD study (GSBR-1290-02 [NCT05762471]).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: GSBR-1290 or Placebo | Experimental | Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks. |
|
| Cohort 2: GSBR-1290 | Experimental | Healthy non-Japanese participants (Caucasians or African Americans) will receive once daily doses of study drug (GSBR-1290 oral capsules) for up to 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSBR-1290 | Drug | Participants will receive GSBR-1290 oral capsules. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious AEs | From start of study drug up to End of study (EOS) (up to Day 42) | |
| Number of Participants Based on Severity of AEs | From start of study drug up to EOS (up to Day 42) | |
| Number of Participants With Clinically Significant Change From Baseline in Vital Signs | Baseline up to EOS (Day 42) | |
| Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline up to EOS (Day 42) | |
| Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters | Baseline up to EOS (Day 42) |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters | 31 days | |
| Analysis of Time to Maximum Observed Plasma Concentration (Tmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters |
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Inclusion Criteria:
For Cohort 1 only:
Japanese participants must have both parents and 4 grandparents of Japanese origin
For Cohort 2 only:
Non-Japanese participants must not have parents and grandparents of Japanese origin. Non-Japanese participants will be limited to Caucasians of European and Latin American descent or African Americans
For Cohorts 1 and 2:
Must have given written informed consent before any study-related activities are carried out
Adult males and females, age 18 to 55 years of age (inclusive) at screening
Body Mass Index (BMI) greater than or equal to (>=) 18.5 and less than or equal to (<=) 24.9 kilogram per square meter (kg/m^2), with a body weight (to 1 decimal place) >= 45.0 kg at screening
No nicotine use
Sitting blood pressure after resting for 5 minutes between 90 to 140 millimeter of mercury (mm Hg) systolic and 50 to 90 mm Hg diastolic and a heart rate between 40 to 100 beats per minute
Have suitable venous access for blood sampling
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ACT | Anaheim | California | 92801 | United States |
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Data sharing requests will be considered beginning 36 months after the study publication (manuscript accepted for publication) and either 1) the product have been granted marketing authorization in at least two regulatory jurisdictions, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Researchers will submit a request containing the research objectives, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Structure Therapeutics does not grant external requests for individual de-identified patient data for the following purposes:
Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a panel of external advisors. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement.
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 31, 2026 | |
| Unrelease | Apr 1, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 31, 2026 | Apr 1, 2026 |
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Study drug (GSBR-1290 or placebo) administration in Cohort 1 is double-blind and Study drug (GSBR-1290) administration in Cohort 2 is open label.
| Placebo | Other | Participants will receive matching placebo oral capsules. |
|
| 31 days |
| Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters | 31 days |
| Analysis of Area Under the Plasma Concentration-time Curve (AUC) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters | 31 days |