VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
- Registration Number
- NCT02955459
- Lead Sponsor
- Venatorx Pharmaceuticals, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VNRX-5133 VNRX-5133 IV infusion Placebo Placebo IV infusion
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events; assessed by patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis. Part 1: 8 days. Part 2: 17 days
- Secondary Outcome Measures
Name Time Method