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

• ClinicalTrials.gov Identifier: NCT04243863
• Recruitment Status: Completed
• First Posted: January 28, 2020
• Last Update Posted: June 15, 2022
• Sponsor: Venatorx Pharmaceuticals, Inc.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): Venatorx Pharmaceuticals, Inc.

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 (Clinical Trial)
• 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: January 20, 2020
• Actual Primary Completion Date: April 5, 2021
• Actual Study Completion Date: April 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 [ Time Frame: Day 8 ]
2. Part 2: Number of subjects with adverse events [ Time Frame: Day 17 ]

Secondary Outcome Measures :

1. Part 1: AUC0-tau [ Time Frame: Days 1-3 ]
2. Part 1: Cmax [ Time Frame: Days 1-3 ]
3. Part 1: tmax [ Time Frame: Days 1-3 ]
4. Part 1: CLr [ Time Frame: Days 1-3 ]
5. Part 2: AUC0-tau [ Time Frame: Days 1-10 ]
6. Part 2: Cmax [ Time Frame: Days 1-10 ]
7. Part 2: tmax [ Time Frame: Days 1-10 ]
8. Part 2: CLr [ Time Frame: Days 1-10 ]

Eligibility Criteria

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

Criteria

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

United States, Texas

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)

More Information

• Responsible Party: Venatorx Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT04243863
• Other Study ID Numbers: VNRX-7145-101; 272201600029C-P00007-9999-2 ( U.S. NIH Grant/Contract ); 18-0012 ( Other Identifier: DMID )
• First Posted: January 28, 2020
• Last Update Posted: June 15, 2022
• Last Verified: June 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