Safety & Tolerability of MEDI3506 in SAD/MAD Study
Research type
Research Study
Full title
A Phase 1, Randomised, Blinded, Placebo-Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of MEDI3506 Administered as Single Ascending Doses in Healthy Adult Subjects with a History of Mild Atopy and as Multiple Ascending Doses in Adult Subjects with Chronic Obstructive Pulmonary Disease and a Single Dose in Healthy Japanese Subjects
IRAS ID
221780
Contact name
Muna Albayaty
Contact email
Sponsor organisation
MedImmune Limited
Eudract number
2016-004257-32
Duration of Study in the UK
1 years, 6 months, 21 days
Research summary
This is a two-part, randomised, blinded, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity following single and repeated doses of MEDI3506 administered by either subcutaneous or intravenous routes, in sequential ascending dose cohorts. The trial will be conducted at multiple clinical sites. In Part I, healthy adult male and female subjects with a history of mild tendency to allergic diseases (atopy) will receive single doses of MEDI3506. In Part II, adult male and female subjects with chronic obstructive pulmonary disease (COPD) will receive 3 repeat doses of MEDI3506 once every two weeks. All female subjects will be of non-childbearing potential. Both study parts will include a screening visit, treatment period and several follow-up outpatient visits. During the treatment period, subjects participating in Part I will be required to stay in-house at the clinical unit and patients in Part II will be required to call on the clinical unit for treatment visits.
This is the first time MEDI3506 is administered in humans. MEDI3506 is being developed for the treatment of moderate-severe COPD. MEDI3506 is a human immunoglobulin monoclonal antibody against interleukin IL-33. The interleukins are a class of special proteins that regulate the functions of white blood cells during infections. It is thought that, through its action on IL-33, MEDI3506 will improve airflow limitation in patients with stable COPD and reduce the incidence and severity of acute episodes of worsening of disease (exacerbations).
The main purpose of the study is to see how safe the study drug is and how well the body tolerates the study drug after single and repeated doses, administered subcutaneously or intravenously to healthy subjects or patients with COPD. The study will also investigate how the study drug is absorbed (taken up into the body), metabolised (chemically broken down), distributed through the body, and excreted (removed from the body) in healthy subjects (referred to as PK). In addition, the study will investigate whether to study drug has provoked an immune response in the body and if antibodies against MEDI3506 have been formed (referred to as immunogenicity).
REC name
London - Hampstead Research Ethics Committee
REC reference
17/LO/0179
Date of REC Opinion
3 Apr 2017
REC opinion
Further Information Favourable Opinion