Assessment of CR8020, a monoclonal antibody, against influenza A
Research type
Research Study
Full title
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
IRAS ID
134515
Contact name
Kingsley Urakpo
Contact email
Sponsor organisation
Crucell Holland B.V
Eudract number
2013-002185-39
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
n/a
Research summary
This is a Phase IIa, randomised, double-blinded study to evaluate the effect of study drug CR8020 compared to placebo (dummy) on the development of clinical influenza symptoms and virus shedding from the nasal mucosa of healthy volunteers.
Volunteers will be screened to identify eligible subjects to participate in the study. Up to 22 volunteers will be dosed with CR8020 or placebo (1:1 ratio) and then inoculated (challenged) with influenza virus.
At the study specific screening visit volunteers will provide informed consent and undergo the scheduled screening assessments which will include a blood test to assess the presence of antibodies to the influenza virus.
If the volunteers fulfil the eligibility criteria they will be asked to attend the Quarantine unit on Day -4/-3 (prior to dosing).Volunteers will be randomised (1:1) to either CR8020 or placebo treatment in a blinded fashion. Eligible volunteers will receive a single dose of CR8020 or placebo on Day -2 via intravenous infusion over a two hour period. Approximately 48 hours after dosing (Day 0), the randomised volunteers will be challenged with the influenza virus strain (A/Wisconsin/67/2005 (H3N2)).
A sentinel group of six volunteers will undergo CR8020 dosing and viral challenge approximately three days before the remaining 16 volunteers are dosed.
Volunteers will remain in the Quarantine unit for approximately 12 days. The quarantine phase will end on Day 7, or longer at the Investigator’s discretion. A 5-day course of anti-viral medication (oseltamivir or appropriate alternative) will commence on Day 6 until Day 10 (3 doses will be taken while in quarantine; the regimen will be completed at home).
Following discharge from quarantine,volunteers will attend follow-up visits at approximately 28 and 96 days after exposure to the study influenza virus.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
13/EE/0236
Date of REC Opinion
30 Aug 2013
REC opinion
Further Information Favourable Opinion