VNRX-5024 Safety and PK in Healthy Adult Volunteers

Venatorx Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: Placebo for VNRX-5024; Drug: VNRX-5024

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT04314206

VNRX-5024-101

17-0004

272201600029C-P00007-9999-2 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy adults 18-55 years
2. Males or non-pregnant, non-lactating females
3. Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2
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 drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug
3. Use of antacid medications
4. Abnormal ECG or history of clinically significant abnormal rhythm disorder
5. Positive alcohol, drug, or tobacco use/test

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

VNRX-5024

Experimental group

Description:

Capsule formulation

Treatment:

Drug: VNRX-5024

Placebo

Placebo Comparator group

Description:

Placebo for VNRX-5024

Treatment:

Drug: Placebo for VNRX-5024