VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers

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

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: VNRX-9945; Drug: Placebo for VNRX-9945

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • New Zealand Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VNRX-9945; Oral dosing	Drug: VNRX-9945; Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
PLACEBO_COMPARATOR: Placebo; Oral dosing	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Number of subjects with adverse events	Up to 8 days after last administration of study drug
Part 2: Number of subjects with adverse events	Up to 8 days after last administration of study drug

Secondary Outcome Measures

Outcome Measure	Time Frame
Part 1: AUC0-tau	Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: Cmax	Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: tmax	Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: AUCinf	Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 1: t1/2	Days 1-6 (Days 1-12 for fasted/fed cohort)
Part 2: AUC0-tau	Day 1 and Following Last Dose on Day 14
Part 2: Cmax	Day 1 and Following Last Dose on Day 14
Part 2: tmax	Day 1 and Following Last Dose on Day 14
Part 2: t1/2	Following Last Dose on Day 14

Collaborators and Investigators

• Sponsor: Venatorx Pharmaceuticals, Inc.
• Collaborators: Novotech (Australia) Pty Limited

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 23, 2021
• Primary Completion (ACTUAL): October 31, 2021
• Study Completion (ACTUAL): October 31, 2021

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 10, 2021
• First Posted (ACTUAL): April 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 14, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: VNRX-9945-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No