VNRX-5024 Safety and PK in Healthy Adult Volunteers

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Subjects

Intervention / Treatment
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* Drug: VNRX-5024
* Drug: Placebo for VNRX-5024


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNRX-5024<br>Capsule formulation | Drug: VNRX-5024<br>* 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)<br>|
| Placebo Comparator: Placebo<br>Placebo for VNRX-5024 | Drug: Placebo for VNRX-5024<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |