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This is a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of VES001 in a two part followed by a multicenter, open-label Phase 1b study in asymptomatic GRN mutation carriers.
Part A will evaluate the safety, tolerability, PK, and PD of single doses of VES001 in healthy volunteers.
Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of VES001 in healthy volunteers.
Full description
Part A will include six cohorts, with eight participants per cohort. Participants in each cohort will be randomised in a 6:2 ratio (VES001 vs. placebo).
Part B will include three cohorts, with ten participants per cohort. Participants in each cohort will be randomised in a 8:2 ratio (VES001 vs. placebo).
Enrollment
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Inclusion and exclusion criteria
Inclusion Criteria Part A & B:
Exclusion Criteria Part A & B:
Primary purpose
Allocation
Interventional model
Masking
78 participants in 2 patient groups, including a placebo group
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Central trial contact
Mads Kjoelby, MD, PhD.; Ditte Mikkelsen, MSc
Data sourced from clinicaltrials.gov
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