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VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT04243863
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : March 11, 2021
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Venatorx Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE January 14, 2020
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date March 11, 2021
Actual Study Start Date  ICMJE January 20, 2020
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Part 1: Number of subjects with adverse events [ Time Frame: Day 8 ]
  • Part 2: Number of subjects with adverse events [ Time Frame: Day 17 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2020)
  • Part 1: AUC0-tau [ Time Frame: Days 1-3 ]
  • Part 1: Cmax [ Time Frame: Days 1-3 ]
  • Part 1: tmax [ Time Frame: Days 1-3 ]
  • Part 1: CLr [ Time Frame: Days 1-3 ]
  • Part 2: AUC0-tau [ Time Frame: Days 1-10 ]
  • Part 2: Cmax [ Time Frame: Days 1-10 ]
  • Part 2: tmax [ Time Frame: Days 1-10 ]
  • Part 2: CLr [ Time Frame: Days 1-10 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers
Official Title  ICMJE A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-7145 in Healthy Adult Volunteers
Brief Summary This is a 2-part, first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: VNRX-7145
    Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
  • Drug: Placebo
    Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
Study Arms  ICMJE
  • Experimental: VNRX-7145
    Oral dosing
    Intervention: Drug: VNRX-7145
  • Placebo Comparator: Placebo
    Oral dosing
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2020)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults 18-45 years
  • Males or non-pregnant, non-lactating females
  • Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
  • Normal blood pressure
  • Normal laboratory tests

Exclusion Criteria:

  • Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  • History of drug allergy
  • Abnormal ECG or history of clinically significant abnormal rhythm disorder
  • Positive alcohol, drug, or tobacco use/test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Venatorx Clinical 610-644-8935 venatorxclinical@venatorx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243863
Other Study ID Numbers  ICMJE VNRX-7145-101
272201600029C-P00007-9999-2 ( U.S. NIH Grant/Contract )
18-0012 ( Other Identifier: DMID )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Venatorx Pharmaceuticals, Inc.
Study Sponsor  ICMJE Venatorx Pharmaceuticals, Inc.
Collaborators  ICMJE National Institute of Allergy and Infectious Diseases (NIAID)
Investigators  ICMJE Not Provided
PRS Account Venatorx Pharmaceuticals, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP