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

Phase 1

Completed

• Conditions: Bacterial Infections
• Interventions: Drug: VNRX-5133; Drug: Placebo

• Registration Number: NCT02955459
• Lead Sponsor: Venatorx Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-02
• Study First Submitted QC: 2016-11-02
• Study First Posted: 2016-11-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-20
• Last Update Posted: 2017-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VNRX-5133	VNRX-5133	IV infusion
Placebo	Placebo	IV infusion

Primary Outcome Measures

Name	Time	Method
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