VNRX-7145 SAD/MAD Safety and PK in Healthy Adult Volunteers

A Randomized, Double Blind, Placebo-Controlled, Sequential Group, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of Single and Repeat Doses of VNRX-7145 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-7145. In part 1, subjects will receive a single dose of VNRX-7145; in part 2 subjects will receive multiple doses of VNRX-7145 for 10 days.

Inclusion Criteria:

• Healthy adults 18-45 years
• Males or non-pregnant, non-lactating females
• Body mass index (BMI): ≥18.5 kg/m² and ≤32.0 kg/m²
• Normal blood pressure
• Normal laboratory tests

Exclusion Criteria:

• Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
• History of drug allergy
• Abnormal ECG or history of clinically significant abnormal rhythm disorder
• Positive alcohol, drug, or tobacco use/test