VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Study Overview
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Brief Summary
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This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

Detailed Description
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In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

Official Title
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Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: VNRX-9945
* Drug: Placebo for VNRX-9945


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) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs) Normal blood pressure Normal lab tests Exclusion Criteria: Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder History of severe allergic or anaphylactic reaction 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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No

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VNRX-9945<br>Oral dosing | Drug: VNRX-9945<br>* Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)<br>|
| Placebo Comparator: Placebo<br>Oral dosing | Drug: Placebo for VNRX-9945<br>* Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: Number of subjects with adverse events |  | Up to 8 days after last administration of study drug | 
| Part 2: Number of subjects with adverse events |  | Up to 8 days after last administration of study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part 1: AUC0-tau |  | Days 1-6 (Days 1-12 for fasted/fed cohort) | 
| Part 1: Cmax |  | Days 1-6 (Days 1-12 for fasted/fed cohort) | 
| Part 1: tmax |  | Days 1-6 (Days 1-12 for fasted/fed cohort) | 
| Part 1: AUCinf |  | Days 1-6 (Days 1-12 for fasted/fed cohort) | 
| Part 1: t1/2 |  | Days 1-6 (Days 1-12 for fasted/fed cohort) | 
| Part 2: AUC0-tau |  | Day 1 and Following Last Dose on Day 14 | 
| Part 2: Cmax |  | Day 1 and Following Last Dose on Day 14 | 
| Part 2: tmax |  | Day 1 and Following Last Dose on Day 14 | 
| Part 2: t1/2 |  | Following Last Dose on Day 14 |