Healthy VolunteersPhase 1NCT05893043
A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants
A Phase 1 study testing GSBR-1290 in people with Healthy Volunteers, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- GSBR-1290
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2023to 28 Jun 2023
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
- Liver function test results elevated > 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
- Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m^2 body surface area
- Known hypersensitivity to any of the study drug ingredients
- Any other condition or prior therapy that would make the participant unsuitable for this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers
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.
Read the detailed description
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]).
- Conditions
- Healthy Volunteers
- Being tested
- GSBR-1290, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSBR-1290Drug
Also called GSBR-1001290
Participants will receive GSBR-1290 oral capsules.
PlaceboOther
Participants will receive matching placebo oral capsules.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GSBR-1290; Other: Placebo |
| 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. Receives: Drug: GSBR-1290 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious AEs
Measured: From start of study drug up to End of study (EOS) (up to Day 42)
Number of Participants Based on Severity of AEs
Measured: From start of study drug up to EOS (up to Day 42)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Measured: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Measured: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Measured: Baseline up to EOS (Day 42)
Secondary outcomes (4)
Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
Measured: 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
Measured: 31 days
Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Measured: 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
Measured: 31 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start24 Apr 2023
- Primary completion28 Jun 2023
- Study completion28 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893043
- Sponsor's protocol ID
- GSBR-1290-03
- Status last verified
- Jul 2023
- First submitted
- 30 May 2023
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05893043
- Acronym / sponsor ID
- GSBR-1290-03
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 28 Jun 2023 (actual)
- Study completion
- 28 Jun 2023 (actual)
- First posted
- 7 Jun 2023 (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 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.
Detailed description
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]).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: GSBR-1290 or Placebo | Experimental | Drug: GSBR-1290, Other: PlaceboHealthy 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 | Drug: GSBR-1290Healthy non-Japanese participants (Caucasians or African Americans) will receive once daily doses of study drug (GSBR-1290 oral capsules) for up to 4 weeks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Japanese participants must have both parents and 4 grandparents of Japanese origin
- 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
- 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
Key exclusion criteria (5 listed)
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or major surgery within the past 3 months
- Liver function test results elevated > 2.0-fold the upper limit of normal (ULN) for gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP), aspartate transaminase (AST) or alanine transaminase (ALT). Bilirubin above ULN
- Estimated glomerular filtration rate (eGFR) < 60 milliliter per minute (mL/min)/1.73m^2 body surface area
- Known hypersensitivity to any of the study drug ingredients
- Any other condition or prior therapy that would make the participant unsuitable for this study
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 |
|---|---|---|
| GSBR-1290Also: GSBR-1001290Participants will receive GSBR-1290 oral capsules. | Drug | Cohort 1: GSBR-1290 or Placebo, Cohort 2: GSBR-1290 |
| PlaceboParticipants will receive matching placebo oral capsules. | Other | Cohort 1: GSBR-1290 or Placebo |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: From start of study drug up to End of study (EOS) (up to Day 42)
Number of Participants Based on Severity of AEs
Time frame: From start of study drug up to EOS (up to Day 42)
Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time frame: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline up to EOS (Day 42)
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters
Time frame: Baseline up to EOS (Day 42)
4 secondary outcomes
Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters
Time frame: 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
Time frame: 31 days
Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters
Time frame: 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
Time frame: 31 days
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 14 Jul 2023.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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Screening Protocol
Pain
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 GSBR-1290 in people with Healthy Volunteers, run by Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics at 1 site in United States.
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 11 inclusion and 5 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 14 Jul 2023. 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 United States. 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?
Number of Participants With Adverse Events (AEs) and Serious AEs (time frame: From start of study drug up to End of study (EOS) (up to Day 42)). The study lists 5 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 14 Jul 2023.