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VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

NCT04243863 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-12-03

No results posted yet for this study

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

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)

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
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2020-01-20
Primary Completion
2021-04-05
Completion
2021-04-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT04243863 on ClinicalTrials.gov