Trials / Completed
CompletedNCT01938352
Evaluation of the Protective Efficacy and Safety of CR8020 in an Influenza Challenge
Randomised, Double-Blind, Placebo-Controlled, Phase IIa Study in Healthy Volunteers to Evaluate the Protective Efficacy and Safety of CR8020 in an Influenza Challenge Model
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Crucell Holland BV · Industry
- Sex
- All
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Accepted
Summary
After prophylactic vaccination with CR8020, a monoclonal antibody, subjects will be challenged with the H3N2 virus. The protective efficacy, safety, tolerability, pharmacokinetics, and potential immunogenicity will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CR8020 | CR8020 15 mg/kg, administered by intravenous infusion |
| BIOLOGICAL | Placebo | Placebo (hydrous dextrose in water for injection), administered by intravenous infusion |
Timeline
- Start date
- 2013-10-02
- Primary completion
- 2014-01-22
- Completion
- 2014-01-22
- First posted
- 2013-09-10
- Last updated
- 2019-04-12
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT01938352. Inclusion in this directory is not an endorsement.