VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers

VNRX-5133-101/102: A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Doses of VNRX-5133 in Healthy Adult Volunteers

This is a 2-part, first-in-human dose-ranging study to evaluate the safety, tolerability and pharmacokinetics of escalating doses of VNRX-5133 administered via intravenous (IV) infusion in healthy subjects. In part 1, subjects will receive a single dose of VNRX-5133; in part 2 subjects will receive VNRX-5133 for 7 days.

Inclusion Criteria:

• Healthy adults
• Males or non-pregnant, non-lactating females
• Body Mass Index (BMI) between 18.5 - 32.0, inclusive.
• Suitable veins for cannulation

Exclusion Criteria:

• Employee of site or the sponsor
• Any disease that poses an unacceptable risk to participants
• Abnormal ECG
• Abnormal labs
• Abnormal vital signs
• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
• Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1
• Current smokers or history of smoking within 30 days