VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lenexa, Kansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults
Males or non-pregnant, non-lactating females
Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
Suitable veins for cannulation

Exclusion criteria

Employee of site or the sponsor
Any disease that poses an unacceptable risk to participants
Abnormal ECG
Abnormal labs
Abnormal vital signs
Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
Current smokers or history of smoking within 30 days

Treatment and study plan

VNRX-5133

Drug

Placebo

Drug

Primary outcomes

Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.

Time frame: Part 1: 8 days. Part 2: 17 days

Sponsors and collaborators

Lead sponsor

Venatorx Pharmaceuticals, Inc.

Industry

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Nov 4, 2016
Registry last updated: Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed