NCT04314206

VNRX-5024 Safety and PK in Healthy Adult Volunteers

A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	VNRX-5024	Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)
DRUG	Placebo for VNRX-5024	Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours \[q12h\] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Timeline

• Start date: 2020-07-27
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-03-19
• Last updated: 2025-12-03

Locations

1 site across 1 country: Netherlands