741806
Last Update Posted: 2010-03-02
Recruiting has ended
Males accepted | 18 Years-50 Years |
32 Estimated Participants | No Expanded Access |
Interventional Study | Accepts healthy volunteers |
Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1 is safe and induces an immune response against influenza A H5N1. This hypothesis will be tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study assessing the safety and tolerability of single dose administration of GHB04L1 in healthy adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.
Eligibility
Relevant conditions:
Influenza
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov