NCT04243863

VNRX-7145 SAD/MAD 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-7145 in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 83 (actual)
• Sponsor: Basilea Pharmaceutica · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VNRX-7145	Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)
DRUG	Placebo	Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Timeline

• Start date: 2020-01-20
• Primary completion: 2021-04-05
• Completion: 2021-04-05
• First posted: 2020-01-28
• Last updated: 2025-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study