VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: VNRX-9945; Drug: Placebo for VNRX-9945

• Registration Number: NCT04845321
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief Summary

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

• Study First Submitted: 2021-04-10
• Study First Submitted QC: 2021-04-10
• Study First Posted: 2021-04-14
• Study Start: 2021-06-23
• Primary Completion: 2021-10-31
• Study Completion: 2021-10-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-14
• Last Update Posted: 2022-06-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VNRX-9945	VNRX-9945	Oral dosing
Placebo	Placebo for VNRX-9945	Oral dosing

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand