NCT04845321

VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Venatorx Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

Detailed description

In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	VNRX-9945	Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
DRUG	Placebo for VNRX-9945	Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Timeline

• Start date: 2021-06-23
• Primary completion: 2021-10-31
• Completion: 2021-10-31
• First posted: 2021-04-14
• Last updated: 2025-06-10

Locations

1 site across 1 country: New Zealand