Evaluation of Safety, Tolerability & PK of CT-P27
Research type
Research Study
Full title
A Phase 1 Randomised, Open Label, Dose-Escalating Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Intravenous CT-P27 with or without Oseltamivir in Healthy Subjects.
IRAS ID
177868
Contact name
David J A Bell
Contact email
Sponsor organisation
Celltrion, Inc.
Eudract number
2015-000987-32
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
This is a dose-escalating study of a new intravenous injection being developed for the treatment of influenza. It will assess the safety and tolerability of CT-P27 alone and in combination with a marketed product.
Exploratory objectives will investigate the immune response and the reaction of the body on the drug.
36 healthy male and female subjects aged between 18 and 55 years will be randomised into 3 single-dose cohorts to receive 3 different strengths of the drug via intravenous infusion with or without the marketed product.
The first dose in cohort 1 will use a sentinel group of two subjects. After 48 hours observation, the remaining 10 subjects will receive the study drug with or without the marketed product provided the safety and tolerability results of the sentinel group are acceptable. The similar approach as in Cohort 1 will apply to Cohort 2 and 3.
A Dose Escalation Committee will decide whether to proceed with administration to the remaining group in all cohorts.
Screening will take place up to 21 days before randomisation.
Participation involves a clinic stay on one occasion for three nights. The study medication will be given via intravenous infusion, the marketed capsules will be taken over Days 1 to 5 of stay in the clinic, and a self-medication period at home.Assessments and blood sampling will be carried out at various time-points until the morning of Day 3, when they will be discharged.
There will be 5 return visits up to Day 78. Those taking the marketed capsules at home on Days 3, 4 and 5 will be asked to keep a medication diary.
Post-study medical will take place on Day 110.
The total time on the study will be approximately 110 days, excluding the screening period.
REC name
HSC REC B
REC reference
15/NI/0063
Date of REC Opinion
5 May 2015
REC opinion
Further Information Favourable Opinion