VNRX-5133 SAD/MAD Safety and PK in Healthy Adult Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 7/22/2017 |
| Start Date: | November 2016 |
| End Date: | June 2017 |
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.
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
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