VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

• Sponsor: Venatorx Pharmaceuticals, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04243863
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Enrollment: 83
• Location: 1
• Arms: 2
• Actual Duration (Months): 14.5
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: VNRX-7145; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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-7145 in Healthy Adult Volunteers
• Actual Study Start Date: Jan 20, 2020
• Actual Primary Completion Date: Apr 5, 2021
• Actual Study Completion Date: Apr 5, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VNRX-7145 Oral dosing	Drug: VNRX-7145; Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
Placebo Comparator: Placebo Oral dosing	Drug: Placebo; Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)

Outcome Measures

Primary Outcome Measures

1. Part 1: Number of subjects with adverse events [Day 8]

2. Part 2: Number of subjects with adverse events [Day 17]

Secondary Outcome Measures

1. Part 1: AUC0-tau [Days 1-3]

2. Part 1: Cmax [Days 1-3]

3. Part 1: tmax [Days 1-3]

4. Part 1: CLr [Days 1-3]

5. Part 2: AUC0-tau [Days 1-10]

6. Part 2: Cmax [Days 1-10]

7. Part 2: tmax [Days 1-10]

8. Part 2: CLr [Days 1-10]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adults 18-45 years

• Males or non-pregnant, non-lactating females

• Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²

• Normal blood pressure

• Normal laboratory tests

Exclusion Criteria:

• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder

• History of drug allergy

• Abnormal ECG or history of clinically significant abnormal rhythm disorder

• Positive alcohol, drug, or tobacco use/test

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Worldwide Clinical Trials Early Phase Services, LLC	San Antonio	Texas	United States	78217

Sponsors and Collaborators

• Venatorx Pharmaceuticals, Inc.
• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Venatorx Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04243863
• Other Study ID Numbers: VNRX-7145-101; 272201600029C-P00007-9999-2; 18-0012
• First Posted: Jan 28, 2020
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Venatorx Pharmaceuticals, Inc.: VNRX-7145; Safety; Pharmacokinetics

Study Results

No Results Posted as of Jun 15, 2022