VNRX-5024 Safety and PK in Healthy Adult Volunteers

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: VNRX-5024; Drug: Placebo for VNRX-5024

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands
    • PRA Health Sciences - Early Development Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
4. Normal blood pressure
5. Normal lab tests

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VNRX-5024; Capsule formulation	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)
Placebo Comparator: Placebo; Placebo for VNRX-5024	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of subjects with adverse events	Day 19

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Part 2: tmax	Days 3-12
Part 1: CLr	Days 1-2
Part 2: CLr	Days 3-12

Collaborators and Investigators

• Sponsor: Venatorx Pharmaceuticals, Inc.
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: March 16, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): June 15, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VNRX-5024-101; 272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract); 17-0004 (DMID)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No