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MEDI-551

Phase 1

Scleroderma | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Nov 13, 2014

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00946699A Study of the Safety and Tolerability of MEDI-551 in SclerodermaPHASE1 COMPLETED 50 — — Mar 1, 2010Mar 1, 2014Nov 13, 201414 United States, Canada +1
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Study Endpoints
Primary Endpoints
The safety and tolerability of MEDI-551 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Day 85
Secondary Endpoints
The secondary endpoints of the study are to assess the PK, IM, and PD of single IV doses of MEDI-551 in adult subjects with scleroderma. Pharmacodynamics will be assessed by numbers of B cells in blood and skin.
Day 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMEDI-551
2EXPERIMENTALMEDI-551
3EXPERIMENTALMEWDI-551
4EXPERIMENTALMEDI-551
5EXPERIMENTALMEDI-551
6PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
MEDI-551BIOLOGICAL0.1 mg/kg
PlaceboBIOLOGICAL0.3 mg/kg
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Male or female subjects * Age ≥ 18 years of age at the time of screening * Written informed consent and HIPAA authorization (applies to covered entities in the USA only) obtained from the subject/legal representative prior to performing any protocol-related procedures, includi...

Countries:United StatesCanadaUnited Kingdom
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