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

November 26, 2025 updated by: Basilea Pharmaceutica

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Worldwide Clinical Trials Early Phase Services, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults 18-45 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
  • Normal blood pressure
  • Normal laboratory tests

Exclusion Criteria:

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of drug allergy
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VNRX-7145
Oral dosing
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)
Placebo Comparator: Placebo
Oral dosing
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: Number of subjects with adverse events
Time Frame: Day 8
Day 8
Part 2: Number of subjects with adverse events
Time Frame: Day 17
Day 17

Secondary Outcome Measures

Outcome Measure
Time Frame
Part 1: AUC0-tau
Time Frame: Days 1-3
Days 1-3
Part 1: Cmax
Time Frame: Days 1-3
Days 1-3
Part 1: tmax
Time Frame: Days 1-3
Days 1-3
Part 1: CLr
Time Frame: Days 1-3
Days 1-3
Part 2: AUC0-tau
Time Frame: Days 1-10
Days 1-10
Part 2: Cmax
Time Frame: Days 1-10
Days 1-10
Part 2: tmax
Time Frame: Days 1-10
Days 1-10
Part 2: CLr
Time Frame: Days 1-10
Days 1-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Basilea Pharmaceutica

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Director: Kamal Hamed, MD, Basilea Pharmaceutica International Ltd, Allschwil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2020

Primary Completion (Actual)

April 5, 2021

Study Completion (Actual)

April 5, 2021

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 24, 2020

First Posted (Actual)

January 28, 2020

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 26, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • VNRX-7145-101
  • 272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract)
  • 18-0012 (Other Identifier: DMID)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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