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

• Status: Completed
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Venatorx Pharmaceuticals, Inc.
• Collaborator: National Institute of Allergy and Infectious Diseases (NIAID)

Criteria

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