GV101 for Clinical Trials

Phase 1

Waitlist Available

Research Sponsored by Graviton Bioscience Corporation

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 up to day 7.

Summary

This trial tests a new drug called GV101 in healthy individuals to see if it is safe and to understand how the body processes it. The study will help determine the right dosage by measuring how much of the drug gets into the bloodstream and how long it stays there.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 7.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 7.

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 7. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Treatment emergent AEs

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Study drug: GV101Experimental Treatment1 Intervention

400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the treatment group, cohort 5 to 7.

Group II: PlaceboPlacebo Group1 Intervention

Matched placebo control 400 mg (10 mL liquid), 800 mg (20 mL liquid), 1600 mg (40mL liquid) of GVS101 will be administered once, orally to subjects in the control group, cohort 5 to 7.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GV101

2021

Completed Phase 1

~20

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