Safety and Pharmacokinetics Study of Human Monoclonal Antibody (AVP-21D9)
| Status: | Archived |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | August 2010 |
| End Date: | June 2011 |
A Randomized, Double-blind, Placebo-controlled, Dose-escalation Study Evaluating Pharmacokinetics and Safety of a Human Monoclonal Antibody (AVP-21D9) in Normal Healthy Volunteers
Primary:
• To compare the safety profile of a single intravenous administration of AVP-21D9 as
compared with Placebo
Secondary:
- To evaluate the pharmacokinetics (PK) of a single intravenous administration of
AVP-21D9
- To evaluate the immunogenicity of AVP-21D9
This is a sequential, dose-escalating healthy volunteer study of the safety and
pharmacokinetics of intravenously-infused AVP-21D9.
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