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

Bacterial Infections Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02955459
• Other study ID #: VNRX-5133-101/102
• Secondary ID: DMID 16-00142722
• Status: Completed
• Phase: Phase 1
• First received: November 2, 2016
• Last updated: July 20, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: VenatoRx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Drug:
• VNRX-5133

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Part 1: 8 days. Part 2: 17 days