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MEDI-557

Phase 1

Healthy | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Oct 7, 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

MEDI-557 · 2 trials · 2 indications

Phase 1 2
NCT01562938MEDI-557 Adult DosingRespiratory Syncytial Virus
COMPLETED42 Analytics
NCT00578682A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557Healthy
COMPLETED31 Analytics
PHASE1COMPLETED
MEDI-557 Adult Dosing
Respiratory Syncytial VirusUnlock trial analytics
PHASE1COMPLETED
A Phase I, Randomized, Double-Blind, Single-Dose, Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-557
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
from time of informed consent through 360 days post dose (approximately 1 year total)

The occurrence of AEs and SAEs

The occurrence of AEs from the period immediately following study drug administration
through 28 days after dosing
The occurrence of laboratory AEs from the period immediately following study drug administration
through 90 days after dosing
The occurrence of SAEs from the period immediately following study drug administration
through 240 days after dosing

Secondary Endpoints

Pharmacokinetic Assessments - Serum
1st dose through 360 days post dose
Occurrence of anti-MEDI-557 antibody - Serum and Nasal Wash
1st dose through 360 days post dose
Pharmacokinetic Assessments - Nasal Wash
1st dose through 360 days post dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATORPlacebo
MEDI-557 low-doseACTIVE_COMPARATOR -
MEDI-557 high-doseACTIVE_COMPARATOR -
1EXPERIMENTALSingle IV dose of 0.3 mg/kg MEDI-557
2EXPERIMENTALSingle IV dose of 3 mg/kg MEDI-557
3EXPERIMENTALSingle IV dose of 15 mg/kg MEDI-557
4EXPERIMENTALSingle IV dose of 30 mg/kg MEDI-557

Interventions

NameTypeDescription
PlaceboDRUGPlacebo
MEDI-557DRUGMEDI-557 low-dose
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 18-45 years * written informed consent obtained from subject prior to performing any protocol related procedures * healthy by medical history and physical exam * females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and ...

Countries:United States
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Frequently asked questions about MEDI-557

What is MEDI-557 used for?

MEDI-557 is an investigational monoclonal antibody being studied for use in healthy adults and in respiratory syncytial virus (RSV). It is in Phase 1 clinical development and is not yet approved by the FDA.

Who makes MEDI-557?

MEDI-557 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN.

What phase is MEDI-557 in?

MEDI-557 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any use.

What clinical trials is MEDI-557 in?

MEDI-557 has been studied in two completed Phase 1 clinical trials: NCT00578682, a dose escalation study in healthy adults, and NCT01562938, a study in adults with respiratory syncytial virus. Both trials were conducted in the United States.

Is MEDI-557 the same as any other drug?

MEDI-557 is a distinct investigational monoclonal antibody developed by AstraZeneca. No alternative names for MEDI-557 have been reported.