NCT00741806

Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: AVIR Green Hills Biotechnology AG · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	GHB04L1	single dose intranasal administration of GHB04L1
OTHER	Placebo	SPGN buffer

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-12-01
• Completion: 2010-03-01
• First posted: 2008-08-26
• Last updated: 2010-03-02

Locations

1 site across 1 country: Austria