VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-20

Study Completion Date

2021-04-05

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-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VNRX-7145

Oral dosing

Group Type EXPERIMENTAL

VNRX-7145

Intervention Type DRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Placebo

Oral dosing

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Interventions

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VNRX-7145

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Intervention Type DRUG

Placebo

Part 1: one dose Part 2: 28 doses (once every 8 hour \[q8h\] dosing for 9 days with a single morning dose on Day 10)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy adults 18-45 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 laboratory tests

Exclusion Criteria

* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
* History of drug allergy
* Abnormal ECG or history of clinically significant abnormal rhythm disorder
* Positive alcohol, drug, or tobacco use/test

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes