VNRX-9945 Safety and Pharmacokinetics 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

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-23

Study Completion Date

2021-10-31

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.

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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.

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-9945

Oral dosing

Group Type EXPERIMENTAL

VNRX-9945

Intervention Type DRUG

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Placebo

Oral dosing

Group Type PLACEBO_COMPARATOR

Placebo for VNRX-9945

Intervention Type DRUG

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Interventions

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VNRX-9945

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Intervention Type DRUG

Placebo for VNRX-9945

Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight \>50 kg (110 lbs)
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 severe allergic or anaphylactic reaction
3. Abnormal ECG or history of clinically significant abnormal rhythm disorder
4. Positive alcohol, drug, or tobacco use/test

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No