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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 cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.
Awards & highlights
Study Summary
This study is evaluating whether a drug called LSD can be safely given to people.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 5 -7: pre-dose and 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, 72 hrs post dose.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Treatment emergent AEs
Secondary outcome measures
GV101 plasma levels will be quantified for PK analysis
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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Graviton Bioscience CorporationLead Sponsor
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