VNRX-5024 Safety and PK in Healthy Adult Volunteers

NCT04314206 | Completed Phase 1

• 3 other identifiers: VNRX-5024-101272201600029C-P00007-9999-217-0004
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of subjects with adverse events

  Day 19

Secondary Outcomes (8)

• Part 1: AUC0-tau

  Days 1-2

• Part 2: AUC0-tau

  Days 3-12

• Part 1: Cmax

  Days 1-2

• Part 2: Cmax

  Days 3-12

• Part 1: tmax

  Days 1-2

Study Arms (2)

VNRX-5024

EXPERIMENTAL

Capsule formulation

Drug: VNRX-5024

Placebo

PLACEBO COMPARATOR

Placebo for VNRX-5024

Drug: Placebo for VNRX-5024

Interventions

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)

Placebo

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)

VNRX-5024

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Basilea Pharmaceutica: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

PRA Health Sciences - Early Development Services

Groningen, Netherlands

Location

Related Publications (1)

• Dorr MB, de Oliveira CF, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Pharmacokinetics and safety of single and repeat doses of ceftibuten in healthy participants: a phase 1 dose escalation study. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0008725. doi: 10.1128/aac.00087-25. Epub 2025 Aug 5.

  PMID: 40762485 DERIVED

Study Officials

• Kamal Hamed, MD

  Basilea Pharmaceutica International Ltd, Allschwil

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 19, 2020
• Study Start: July 27, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: December 3, 2025

Record last verified: 2025-11

Locations

NL (1)