← Back to Search

Unknown

Cohort 2: GSBR-1290 for Healthy Subjects

Phase 1

Waitlist Available

Research Sponsored by Gasherbrum Bio, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to eos (day 42)

Awards & highlights

Study Summary

This trial is testing a new drug to see if it's safe and tolerable in healthy Japanese and non-Japanese adults.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to eos (day 42)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to eos (day 42)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to eos (day 42) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants Based on Severity of AEs

Number of Participants With Adverse Events (AEs) and Serious AEs

Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters

+2 more

Secondary outcome measures

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

Analysis of Maximum Observed Plasma Concentration (Cmax) for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate Pharmacokinetic (PK) Parameters

Analysis of Plasma Trough Concentrations for GSBR-1290 at Specified Timepoints Pre-dose and Post-dose to Calculate PK Parameters

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2: GSBR-1290Experimental Treatment1 Intervention

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.

Group II: Cohort 1: GSBR-1290 or PlaceboExperimental Treatment2 Interventions

Healthy Japanese participants will receive once daily doses of study drug (GSBR-1290 or placebo oral capsules) for up to 4 weeks.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GSBR-1290

2023

Completed Phase 1

~20

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Gasherbrum Bio, IncLead Sponsor

2 Previous Clinical Trials

214 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can join the experiment for this research project?

"To be eligible for this research initiative, potential participants must meet certain health criteria and fall within the 18-55 age range. A total of eighteen individuals are desired by the medical team."

Answered by AI

Is there an age restriction for enrolment in this research study?

"The age bracket for enrolment in this clinical trial is between 18 to 55 years old. There are a separate set of 55 studies directed towards minors and another 370 research initiatives exclusively targeting seniors."

Answered by AI

What risks have been associated with Cohort 2: GSBR-1290?

"Due to the preliminary nature of this Phase 1 trial, our experts at Power gave Cohort 2: GSBR-1290 a score of 1 on a scale from 1 to 3 for safety. This is because there are only minimal reports regarding its efficacy and security."

Answered by AI

Is admission to the research still open for participants?

"Affirmative. According to clinicialtrials.gov, this investigation is currently accepting participants; it was initially uploaded on April 24th 2023 and revised as of May 30th 2023. The research requires 18 volunteers from one medical location."

Answered by AI

How many individuals are currently partaking in this experiment?

"Affirmative, the data hosted on clinicaltrials.gov announces that this research is currently recruiting participants. This trial was first announced to the public on April 24th 2023 and has seen its most recent update occur at the end of May in 2023. 18 individuals are needed from one medical centre for participation."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants

2023. "A Study of Multiple Ascending Doses of GSBR-1290 in Japanese and Non-Japanese Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05893043.