Healthy Volunteers
Conditions
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.
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.
Interventions
DRUGVNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
DRUGPlacebo for VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
Sponsors
Novotech (Australia) Pty Limited
Venatorx Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Number of subjects with adverse events | Up to 8 days after last administration of study drug |
| Part 2: Number of subjects with adverse events | Up to 8 days after last administration of study drug |
Secondary
| Measure | Time frame |
|---|---|
| Part 2: AUC0-tau | Day 1 and Following Last Dose on Day 14 |
| Part 2: Cmax | Day 1 and Following Last Dose on Day 14 |
| Part 2: tmax | Day 1 and Following Last Dose on Day 14 |
| Part 1: AUCinf | Days 1-6 (Days 1-12 for fasted/fed cohort) |
| Part 1: AUC0-tau | Days 1-6 (Days 1-12 for fasted/fed cohort) |
| Part 1: Cmax | Days 1-6 (Days 1-12 for fasted/fed cohort) |
| Part 1: tmax | Days 1-6 (Days 1-12 for fasted/fed cohort) |
| Part 2: t1/2 | Following Last Dose on Day 14 |
| Part 1: t1/2 | Days 1-6 (Days 1-12 for fasted/fed cohort) |
Countries
New Zealand
Outcome results
None listed