Safety & tolerability of MEDI9314 as SAD in healthy subjects
Research type
Research Study
Full title
A Phase 1a Randomized, Blinded, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI9314 in Healthy Adult Subjects
IRAS ID
194932
Contact name
Muna Albayaty
Contact email
Sponsor organisation
MedImmune Limited
Eudract number
2015-004383-11
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 7 days
Research summary
The new medicine tested in this study is a compound called MEDI9314 (referred to as the “study drug”) throughout the remainder of this document. \n\nThe main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted.\n\nThe study will be conducted at 2 sites; 1 site in the United Kingdom (UK) for Cohorts 1-5 and 1 site in the United States of America (USA) for the Japanese Cohort (Japanese subjects only). This study will recruit healthy males and females (non-childbearing potential) between the ages of 18 and 50 years (inclusive). A total of 44 subjects will take part in the study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
16/SC/0014
Date of REC Opinion
28 Jan 2016
REC opinion
Further Information Favourable Opinion