VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

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

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

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.

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