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

NCT06721091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

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.

Sponsors & Collaborators

  • Biotrial

    collaborator INDUSTRY

  • VANDRIA

    lead INDUSTRY

Principal Investigators

  • Klaus Dugi, MD · Vandria SA

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-03
Primary Completion
2025-11-27
Completion
2025-11-27

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06721091 on ClinicalTrials.gov