Trial | NCT02955459  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    84
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.
Study Started
Nov 30
2016
Primary Completion
Jun 30
2017
Study Completion
Jun 30
2017
Last Update
Jul 21
2017

Drug VNRX-5133

Drug Placebo

VNRX-5133 Experimental

IV infusion

Placebo Placebo Comparator

IV infusion

Criteria 

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
No Results Posted