VNRX-5024 Safety and PK in Healthy Adult Volunteers

Healthy Subjects Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-5024 Administered Orally for 10 Days in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04314206
• Other study ID #: VNRX-5024-101
• Secondary ID: 272201600029C-P0
• Status: Completed
• Phase: Phase 1
• Start date: July 27, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2022
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• VNRX-5024
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)
• Placebo for VNRX-5024
Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences - Early Development Services	Groningen

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		Day 19
Secondary	Part 1: AUC0-tau		Days 1-2
Secondary	Part 2: AUC0-tau		Days 3-12
Secondary	Part 1: Cmax		Days 1-2
Secondary	Part 2: Cmax		Days 3-12
Secondary	Part 1: tmax		Days 1-2
Secondary	Part 2: tmax		Days 3-12
Secondary	Part 1: CLr		Days 1-2
Secondary	Part 2: CLr		Days 3-12