ACT
Anaheim, California, 92801, United States
NCT Number: NCT05893043
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Anaheim, California, 92801, United States
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]).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
For Cohort 1 only:
For Cohort 2 only:
For Cohorts 1 and 2:
Exclusion criteria
Participants will receive GSBR-1290 oral capsules.
Other names: GSBR-1001290
Participants will receive matching placebo oral capsules.
Time frame: From start of study drug up to End of study (EOS) (up to Day 42)
Time frame: From start of study drug up to EOS (up to Day 42)
Time frame: Baseline up to EOS (Day 42)
Time frame: Baseline up to EOS (Day 42)
Time frame: Baseline up to EOS (Day 42)
Time frame: 31 days
Time frame: 31 days
Time frame: 31 days
Time frame: 31 days
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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