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MEDI-563

Phase 1

Asthma | Monoclonal antibody | Respiratory |AstraZeneca PLC|Last Updated: Oct 10, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment69

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-563 · 2 trials · 1 indication

Phase 1 2
NCT00659659A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With AsthmaAsthma
COMPLETED27 Analytics
NCT00512486A Sequential Dose-Escalation Study in Subjects With Mild AsthmaAsthma
COMPLETED42 Analytics
PHASE1COMPLETED
A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With Asthma
AsthmaUnlock trial analytics
PHASE1COMPLETED
A Sequential Dose-Escalation Study in Subjects With Mild Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety and tolerability of MEDI-563 in adults with atopic asthma and evaluate the effects of MEDI-563 on eosinophil counts in airway mucosal biopsies 28 days after completion of dosing in adults with atopic asthma.
Study Day 84 or Day 140 - (dose-driven)
The primary endpoint will be the overall incidence of adverse events reported in each dose group.
Day 84

Secondary Endpoints

Evaluate the pharmacokinetics (PK) of MEDI-563 in adults with atopic asthma, and evaluate the immunogenicity (IM) of MEDI-563 in adults with atopic asthma.
Day 84 or 140
Laboratory assessments of safety (hematology, biochemistry and urinalysis), assessments of immunogenicity, vital signs, physical examinations, and ECGs.
Day 84
Safety will also be assessed by measurement of T-cell, B-cell, and NK counts using fluorescence activated cell sorter (FACS) technology.
Day 84
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALMEDI-563
2EXPERIMENTALMEDI-563
4PLACEBO_COMPARATORPlacebo
5PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
MEDI-563DRUG1.0 mg/kg IV: MEDI-563
Placebo Comp.OTHERPlacebo SC
PlaceboOTHERPlacebo as a single IV infusion (Certain number of subjects)
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites11

Inclusion Criteria: * Male or female adults, 18 through 65 years of age at time of randomization; * Written informed consent obtained from the subject prior to beginning study procedures or receipt of any study medication; * Previously documented diagnosis of asthma of ≥ 1 year duration, based on e...

Countries:United StatesCanada
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Frequently asked questions about MEDI-563

What is MEDI-563 used for?

MEDI-563 is an investigational monoclonal antibody being developed for the treatment of asthma. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

Who makes MEDI-563?

MEDI-563 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The drug is in Phase 1 clinical development for the treatment of asthma.

What phase is MEDI-563 in?

MEDI-563 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. Two Phase 1 clinical trials have been completed, but the drug is not yet approved for any use.

What clinical trials is MEDI-563 in?

MEDI-563 has been studied in two completed Phase 1 clinical trials. The first trial, NCT00512486, was a sequential dose-escalation study in subjects with mild asthma, enrolling 42 participants. The second trial, NCT00659659, evaluated safety, tolerability, and effects in adults with asthma, enrolling 27 participants.

Is MEDI-563 the same as benralizumab?

MEDI-563 is an alternative name for benralizumab, a monoclonal antibody being developed by AstraZeneca for the treatment of asthma. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.