Recent Updates
Recently added Catalysts

MEDI-563

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment69
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00659659A Study to Evaluate the Safety, Tolerability and Effects of MEDI-563 in Adults With AsthmaPHASE1 COMPLETED 27Jan 1, 2008Mar 1, 2011Oct 10, 201211 United States, Canada
NCT00512486A Sequential Dose-Escalation Study in Subjects With Mild AsthmaPHASE1 COMPLETED 42Nov 1, 2006Oct 1, 2008Nov 27, 20083 United States
Unlock Drug Trial Details
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
Unlock Study Endpoints
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)
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 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
Unlock Eligibility Criteria