VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Venatorx Pharmaceuticals

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo for VNRX-9945; Drug: VNRX-9945

Study type: Interventional

Funder types: Industry

Identifiers

NCT04845321

VNRX-9945-101

Details and patient eligibility

About

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

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

VNRX-9945

Experimental group

Description:

Oral dosing

Treatment:

Drug: VNRX-9945

Placebo

Placebo Comparator group

Description:

Oral dosing

Treatment:

Drug: Placebo for VNRX-9945