Phase 1 Single Ascending Dose Study
Research type
Research Study
Full title
A Phase 1 Randomized, Blinded, Placebo-controlled, Single ascending Dose Study to Evaluate the Safety and Tolerability of MEDI4920 in Healthy Adults
IRAS ID
152961
Contact name
Jim Bush
Contact email
Sponsor organisation
MedImmune Ltd a subsidiary of Astra Zeneca
Eudract number
2013-004754-16
Clinicaltrials.gov Identifier
02151110
Research summary
MEDI4920 is an investigational drug which is being developed as a potential treatment for some autoimmune diseases (diseases caused by the body’s immune system attacking substances and tissues normally present in the body) such as Sjogren’s Syndrome (pSS) and idiopathic thrombocytopenic purpura (ITP).
pSS is a disease that causes the body to attack the person’s own saliva and tear producing glands. This leads to extreme dryness of the eyes and mouth. pSS can also affect other areas of the body such as muscles, skin, blood, lungs, kidneys, and nerves.ITP is caused by the body attacking and destroying its own platelets (platelets are found in the blood and help the blood to clot). Patients with ITP are at risk of bleeding which can be severe and even fatal if platelet counts are very low.
MEDI4920 is a protein that may block the bodies attack on itself and therefore expected to prevent the destruction of platelets (in ITP) and tear and saliva producing gland (in pSS).
This Study is the first time that MEDI4920 is being given to humans. It has been tested extensively in animals, no adverse effects were seen in animals dosed with a dose approximately 2-fold higher than the highest dose planned for this Study.In this study, healthy subjects will receive a single intravenous dose of MEDI4920 or placebo.
Subject participation is expected to last up to 20 weeks from the time of screening till the last post-study visit.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
14/NW/0194
Date of REC Opinion
1 May 2014
REC opinion
Further Information Favourable Opinion