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VNRX-7145 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243863
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 30, 2020
Sponsor:
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
VenatoRx Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: VNRX-7145 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 20, 2020
Estimated Primary Completion Date : June 24, 2020
Estimated Study Completion Date : June 24, 2020

Arm Intervention/treatment
Experimental: VNRX-7145
Oral dosing
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)

Placebo Comparator: Placebo
Oral dosing
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)




Primary Outcome Measures :
  1. Part 1: Number of subjects with adverse events [ Time Frame: Day 8 ]
  2. Part 2: Number of subjects with adverse events [ Time Frame: Day 17 ]

Secondary Outcome Measures :
  1. Part 1: AUC0-tau [ Time Frame: Days 1-3 ]
  2. Part 1: Cmax [ Time Frame: Days 1-3 ]
  3. Part 1: tmax [ Time Frame: Days 1-3 ]
  4. Part 1: CLr [ Time Frame: Days 1-3 ]
  5. Part 2: AUC0-tau [ Time Frame: Days 1-10 ]
  6. Part 2: Cmax [ Time Frame: Days 1-10 ]
  7. Part 2: tmax [ Time Frame: Days 1-10 ]
  8. Part 2: CLr [ Time Frame: Days 1-10 ]


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 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

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): NCT04243863


Contacts
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Contact: Venatorx Clinical 610-644-8935 venatorxclinical@venatorx.com

Locations
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United States, Texas
Worldwide Clinical Trials Early Phase Services, LLC Recruiting
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
VenatoRx Pharmaceuticals, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)

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Responsible Party: VenatoRx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04243863    
Other Study ID Numbers: VNRX-7145-101
272201600029C-P00007-9999-2 ( U.S. NIH Grant/Contract )
18-0012 ( Other Identifier: DMID )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 30, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VenatoRx Pharmaceuticals, Inc.:
VNRX-7145
Safety
Pharmacokinetics