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VNRX-5024 Safety and PK in Healthy Adult Volunteers

NCT04314206 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-12-03

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • Basilea Pharmaceutica

    lead INDUSTRY

Principal Investigators

  • Kamal Hamed, MD · Basilea Pharmaceutica International Ltd, Allschwil

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-27
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Netherlands

Study Locations

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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 NCT04314206 on ClinicalTrials.gov