None listed
Conditions
Brief 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.
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 ava
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.
Sponsors
Vigil Neuroscience, Inc
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Males and females between 18 to 55 years of age, inclusive, at the Screening Visit.
Exclusion criteria
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.
Outcome results
None listed