drugset / Trial / NCT06226064

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy Participants

NCT06226064 ↗

Phase 1 Completed 78 enrolled Vesper Biotechnologies ApS
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2023-10-11
Primary completion
2024-07-26
Completion
2024-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject VES001 Unknown — Oral