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Completed

NCT Number: NCT04314206

VNRX-5024 Safety and PK in Healthy Adult Volunteers

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences - Early Development Services

Groningen, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adults 18-55 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 lab tests

Exclusion criteria

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
  • Use of antacid medications
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test

Treatment and study plan

VNRX-5024

Drug

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)

Placebo for VNRX-5024

Drug

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)

Primary outcomes

  1. Number of subjects with adverse events

    Time frame: Day 19

Secondary outcomes

  1. Part 1: AUC0-tau

    Time frame: Days 1-2

  2. Part 2: AUC0-tau

    Time frame: Days 3-12

  3. Part 1: Cmax

    Time frame: Days 1-2

  4. Part 2: Cmax

    Time frame: Days 3-12

  5. Part 1: tmax

    Time frame: Days 1-2

  6. Part 2: tmax

    Time frame: Days 3-12

  7. Part 1: CLr

    Time frame: Days 1-2

  8. Part 2: CLr

    Time frame: Days 3-12

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 19, 2020
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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