VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Phase 1TerminatedNCT04845321

Venatorx Pharmaceuticals, Inc.32 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

VNRX-9945DRUG

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

Placebo for VNRX-9945DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

New Zealand Clinical Research

Auckland, New Zealand

Outcomes

Primary Outcomes

Part 1: Number of subjects with adverse events

Time frame: Up to 8 days after last administration of study drug

Part 2: Number of subjects with adverse events

Time frame: Up to 8 days after last administration of study drug