VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

Healthy Volunteers Clinical Trial

Official title:

Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04845321
• Other study ID #: VNRX-9945-101
• Status: Terminated
• Phase: Phase 1
• Start date: June 23, 2021
• Est. completion date: October 31, 2021

Study information

• Verified date: June 2022
• Source: Venatorx Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
New Zealand	New Zealand Clinical Research	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Venatorx Pharmaceuticals, Inc.	Novotech (Australia) Pty Limited

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of subjects with adverse events		Up to 8 days after last administration of study drug
Primary	Part 2: Number of subjects with adverse events		Up to 8 days after last administration of study drug
Secondary	Part 1: AUC0-tau		Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary	Part 1: Cmax		Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary	Part 1: tmax		Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary	Part 1: AUCinf		Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary	Part 1: t1/2		Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary	Part 2: AUC0-tau		Day 1 and Following Last Dose on Day 14
Secondary	Part 2: Cmax		Day 1 and Following Last Dose on Day 14
Secondary	Part 2: tmax		Day 1 and Following Last Dose on Day 14
Secondary	Part 2: t1/2		Following Last Dose on Day 14