Your session is about to expire
← Back to Search
Other
Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects
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.
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
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Graviton Bioscience CorporationLead Sponsor