A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability, Pharmacokinetics of VGL101 in Healthy Adults
Vigil Neuroscience, Inc
30 participants
Jul 22, 2022
Interventional
Conditions
Summary
A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics. VGL101 or placebo will be administered to healthy volunteers to test if VGL101 is safe and can be explored as a treatment for Adult onset leukoencephalopathy with axonal spheroids and pigmented glia.
Eligibility
Inclusion Criteria1
- Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
Exclusion Criteria2
- Participant has any concurrent disease or condition that, in the opinion of the PI, would
- make the participant unsuitable for participation in the clinical study.
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Interventions
VGL101 will be administered via intravenous infusion once in the single ascending dose (cohorts 1A-8A) part, and three times (every 28 days) in the multiple ascending dose (cohorts 1B-4B) part. The starting dose of VGL101 will be 1mg/kg and each cohort will increase by 2-3x. The doses selected for the multiple ascending dose cohorts will be selected after a review of the single ascending dose data by a safety review committee. The safety review committee will review safety, laboratory and available pharmacokinetic/pharmacodynamic data.
Locations(1)
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ACTRN12622000933752