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VNRX-9945 Safety and Pharmacokinetics 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: NCT04845321
Recruitment Status : Recruiting
First Posted : April 14, 2021
Last Update Posted : July 8, 2021
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
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-9945.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: VNRX-9945 Drug: Placebo for VNRX-9945 Phase 1

Detailed Description:
In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
Actual Study Start Date : June 23, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Arm Intervention/treatment
Experimental: VNRX-9945
Oral dosing
Drug: VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)

Placebo Comparator: Placebo
Oral dosing
Drug: Placebo for VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)




Primary Outcome Measures :
  1. Part 1: Number of subjects with adverse events [ Time Frame: Up to 8 days after last administration of study drug ]
  2. Part 2: Number of subjects with adverse events [ Time Frame: Up to 8 days after last administration of study drug ]

Secondary Outcome Measures :
  1. Part 1: AUC0-tau [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  2. Part 1: Cmax [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  3. Part 1: tmax [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  4. Part 1: AUCinf [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  5. Part 1: t1/2 [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  6. Part 2: AUC0-tau [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  7. Part 2: Cmax [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  8. Part 2: tmax [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  9. Part 2: t1/2 [ Time Frame: Following Last Dose on Day 14 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Healthy adults 18-55 years
  2. Males or non-pregnant, non-lactating females
  3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs)
  4. Normal blood pressure
  5. Normal lab tests

Exclusion Criteria:

  1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  2. History of severe allergic or anaphylactic reaction
  3. Abnormal ECG or history of clinically significant abnormal rhythm disorder
  4. 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): NCT04845321


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

Locations
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New Zealand
New Zealand Clinical Research Recruiting
Auckland, New Zealand
Sponsors and Collaborators
Venatorx Pharmaceuticals, Inc.
Novotech (Australia) Pty Limited
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Responsible Party: Venatorx Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04845321    
Other Study ID Numbers: VNRX-9945-101
First Posted: April 14, 2021    Key Record Dates
Last Update Posted: July 8, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No