NCT06721091

Safety, Tolerability, and Dose Response of VNA-318 in Healthy Males

A Phase 1, Randomized, Double-blind, Placebo-controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of VNA-318 in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: VANDRIA · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, double-blind, placebo-controlled study investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending doses (SAD) and multiple ascending doses (MAD) of VNA-318 in healthy male subjects.

Detailed description

The First-in-Human phase I, single center study investigating VNA-318, administered orally, will consist of 2 parts: * Part 1 SAD, conducted in 5 to 8 cohorts of 8 healthy male subjects per dose level, including one optional exploratory cohort with cerebrospinal fluid (CSF) sampling * Part 2 MAD, conducted in 3 to 4 cohorts of 12 healthy male subjects per dose level Subjects will be included in either Part 1 or 2. A Study Safety Committee is involved and will make recommendations on the study advancement, i.e. the dose for the next planned cohort. The doses of the MAD part will be selected by this Study Safety Committee and will be based upon safety and tolerability assessments, the observed PK and, if available and applicable, PD data from SAD.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	VNA-318	Part 1 will consist of administration of VNA-318 at the doses of 5 mg to 180 mg in 5 to 8 successive cohorts. Part 2 will consist of administration of VNA-318 in 3 to 4 successive cohorts. The doses will be selected based on safety and tolerability assessments, as well as PK and, if applicable, PD data from SAD. Once PK suggests that the therapeutic dose has been reached in the SAD part, the SAD and MAD parts of the study could be run in parallel.
DRUG	Placebo	Part 1 (SAD) will consist of administration of matching placebo at the doses of 5 mg to 180 mg in 5 to 8 successive cohorts. Part 2 (MAD) will consist of administration of matching placebo in 3 to 4 successive cohorts. The doses will be selected based on safety and tolerability assessments, as well as PK and, if applicable, PD data from SAD.

Timeline

• Start date: 2024-12-03
• Primary completion: 2025-11-27
• Completion: 2025-11-27
• First posted: 2024-12-06
• Last updated: 2025-12-10

Locations

1 site across 1 country: France