Phase1a, Safety, Randomized, Placebo-controlled, SAD Study of MEDI7836
Research type
Research Study
Full title
A Phase 1a, Randomised, Placebo-controlled, Single-ascending Dose Study to Evaluate the Safety and Tolerability of MEDI7836 in Healthy Adults
IRAS ID
171123
Contact name
Annelize Koch
Contact email
Sponsor organisation
MedImmune
Eudract number
2014-004934-24
Duration of Study in the UK
1 years, 0 months, 24 days
Research summary
This is a first-in-human study, which means that this is the first time that the study drug will be given to humans. Up to now, it has only been tested in animals.
The Sponsor is developing a new medicine called MEDI7836 for the treatment of Asthma. MEDI7836 is a human antibody that works by supressing the effects of a protein called interleukin-13. An antibody is a type of protein produced by the immune system to help defend against bacteria, viruses and other substances that appear foreign and harmful.
Interleukin-13 is produced by the body and may cause asthma to worsen.The main purpose of the study is to:
• See how safe MEDI7836 is and how well it is tolerated after dosing.
• Investigate how MEDI7836 is taken up inside the body, metabolised (chemically broken down), distributed through the body and excreted.
• Investigate the potential of MEDI7836 to cause an immune response by checking whether subjects develop antibodies against MEDI7836.
• Investigate if MEDI7836 affects levels of interleukin-13 and another molecule present in the blood (periostin) whose level is related to the amount of interleukin-13.
In this study, subjects will receive a single dose of the MEDI7836 or placebo. A placebo is a "dummy treatment" that looks like MEDI7836 but has no active ingredients. Subjects will receive the study drug or placebo in the form of injection(s) given into their abdomen as a subcutaneous (SC) (under the skin) injection(s).
This study will recruit healthy, non-smoking, males and females (of non-childbearing potential), between 18 and 50 years of age. Thirty-two (32) subjects will take part in the study.
Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples to measure the amount of study medication in the blood will be collected.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0006
Date of REC Opinion
13 Feb 2015
REC opinion
Favourable Opinion