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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02955459
Recruitment Status : Completed
First Posted : November 4, 2016
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
VenatoRx Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bacterial Infections Drug: VNRX-5133 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
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
Study Start Date : November 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: VNRX-5133
IV infusion
 Drug: VNRX-5133
Placebo Comparator: Placebo
IV infusion
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955459


Locations
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United States, Kansas
Lenexa, Kansas, United States
Sponsors and Collaborators
VenatoRx Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
More Information
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Responsible Party: VenatoRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02955459    
Other Study ID Numbers: VNRX-5133-101/102
DMID 16-0014 ( Other Identifier: DMID )
272201300019C-3-0-1 ( U.S. NIH Grant/Contract )
First Posted: November 4, 2016    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Keywords provided by VenatoRx Pharmaceuticals, Inc.:
Healthy volunteers
Pharmacokinetics
Additional relevant MeSH terms:
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Bacterial Infections