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Medi-524

Phase 1

Respiratory Syncytial Virus Infections | Monoclonal antibody | Infectious Disease |AstraZeneca PLC|Last Updated: Jan 29, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment247

FDA Designations

No designations recorded

Clinical trial landscape

Medi-524 · 2 trials · 1 indication

Phase 1 2
NCT00192478Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524Respiratory Syncytial Virus Infections
COMPLETED217 Analytics
NCT00192465Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy AdultsRespiratory Syncytial Virus Infections
COMPLETED30 Analytics
PHASE1COMPLETED
Open-Label, Dose-Escalation Study of 2 to 5 IM Doses of MEDI-524 at 3 mg/kg or 15 mg/kg; Children to be Followed for 90 Days After Their Last Dose of MEDI-524
Respiratory Syncytial Virus Infections
NCT00192478217
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PHASE1COMPLETED
Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI-524 in Healthy Adults
Respiratory Syncytial Virus Infections
NCT0019246530
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Study Endpoints

Primary Endpoints

Describe the safety and tolerability of repeated IM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals in children at risk for serious RSV disease
30 days after patient's final dose of study drug
Pharmacokinetics of MEDI-524
· Serum concentrations at each data collection visit will be summarized
Safety
30 days after patient's final dose of study drug
Pharmacokinetics
Study Day 0 and 60, 90 days after dose 1; and 7, 30, 60, 90 days after dose 2.
Immunogenicity
150 days after final dose

Secondary Endpoints

Immunogenicity of MEDI-524
· Serum ELISA binding activity at each data collection visit will be summarized
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORMEDI-524
2EXPERIMENTALMEDI-524 (Numax-TM)
3EXPERIMENTALMEDI-524 (Numax-TM)
4EXPERIMENTALMEDI-524 (Numax-TM)
5EXPERIMENTALMEDI-524 (Numax-TM)

Interventions

NameTypeDescription
Medi-524BIOLOGICALIM doses of MEDI-524 administered at 3 mg/kg or 15 mg/kg at 30 day intervals
MEDI-524 (Numax-TM)BIOLOGICALGrp.1: 3 mg/kg IV (single dose)
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Eligibility Criteria

Age Range6 Months to 24 Months
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * All male or female children must have met all the following criteria: * \[Groups 1, 2, and 3\] The child must have been born at ³32 to £35 weeks gestation and have been £6 months of age at the time of entry into the study (child must have been entered on or before their 6-mont...

Countries:ArgentinaChileUnited States
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Frequently asked questions about Medi-524

What is MEDI-524 used for?

MEDI-524 is an investigational monoclonal antibody being developed for Respiratory Syncytial Virus (RSV) Infections. It is currently in Phase 1 clinical development and is not approved by the FDA. The drug is being studied for its safety, tolerability, and pharmacokinetics in healthy adults and in children.

What does MEDI-524 target?

MEDI-524 is a monoclonal antibody designed to target Respiratory Syncytial Virus (RSV). As an antibody, it is intended to neutralize the virus and prevent infection. The specific molecular target has not been disclosed in available clinical trial information.

Who makes MEDI-524?

MEDI-524 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the drug's safety and efficacy for Respiratory Syncytial Virus Infections.

What phase is MEDI-524 in?

MEDI-524 is in Phase 1 clinical development. Two Phase 1 trials have been completed, involving a total of 247 participants. The drug is investigational and has not received FDA approval. It is being studied for the prevention or treatment of Respiratory Syncytial Virus Infections.

What clinical trials is MEDI-524 in?

MEDI-524 has been studied in two completed Phase 1 trials. NCT00192465 evaluated safety, tolerability, and pharmacokinetics in 30 healthy adults in the United States. NCT00192478 was an open-label, dose-escalation study in 217 children in Argentina and Chile, testing 3 mg/kg or 15 mg/kg doses.

Is MEDI-524 the same as other RSV antibodies?

MEDI-524 is a distinct investigational monoclonal antibody for Respiratory Syncytial Virus (RSV) Infections. It is not the same as other approved RSV antibodies, such as palivizumab, which is a different product. MEDI-524 is being developed by AstraZeneca and is currently in Phase 1 trials.