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MEDI5884 Dose 1

Phase 1

Healthy Volunteers | Monoclonal antibody | Other |AstraZeneca PLC|Last Updated: Aug 22, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

MEDI5884 Dose 1 · 1 trial · 1 indication

Phase 1 1
NCT03001297Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884Healthy Volunteers
COMPLETED64 Analytics
PHASE1COMPLETED
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884
Healthy Volunteers
NCT0300129764
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Study Endpoints

Primary Endpoints

Number of subjects with adverse events as a measure of safety and tolerability of MEDI5884
Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

HDL-Cholesterol over time
Baseline until last follow-up visit, assessed up to 90 days post dose depending on cohort.

Secondary Endpoints

Lipoprotein particle size
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Lipoprotein particle number
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
Levels of total cholesterol
Cohort 1: 28 days post dosing, Cohort 2: 45 days post dosing , Cohort 3: 60 days post dosing, Cohort 4: 90 days posting dosing, Optional Japanese American cohort: 60 days posting dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
MEDI5884 Dose 1EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 1 injection SC on Day 1.
PlaceboPLACEBO_COMPARATORPlacebo will be administered subcutaneously (SC).
MEDI5884 Dose 2EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 2 injection SC on Day 1.
MEDI5884 Dose 3EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 3 injection SC on Day 1.
MEDI5884 Dose 4EXPERIMENTALParticipants will receive single dose of MEDI5884 Dose 4 injection SC on Day 1.

Interventions

NameTypeDescription
PlaceboBIOLOGICALParticipants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
MEDI5884 Dose 1BIOLOGICALParticipants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
MEDI5884 Dose 2BIOLOGICALParticipants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
MEDI5884 Dose 3BIOLOGICALParticipants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
MEDI5884 Dose 4BIOLOGICALParticipants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy volunteers aged 18-55 years * Must provide written informed consent * Ability and willingness to adhere to the protocol * BMI 18-30kg/m2 * Females not of childbearing potential * Males must practice 2 effective contraceptive measures if sexually active * Japanese desce...

Countries:United States
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Frequently asked questions about MEDI5884 Dose 1

What is MEDI5884 used for?

MEDI5884 is an investigational small molecule being studied for stable coronary heart disease. It has also been evaluated in healthy volunteers to assess its safety and pharmacological effects. The drug is in Phase 2 clinical development for the cardiovascular condition.

Who makes MEDI5884?

MEDI5884 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 in patients with stable coronary heart disease.

What phase is MEDI5884 in?

MEDI5884 is currently in Phase 2 clinical development. A Phase 2 study has been completed in adults with stable coronary heart disease, and a Phase 1 study in healthy volunteers has also been completed. The drug is not yet approved and remains investigational.

What clinical trials is MEDI5884 in?

MEDI5884 has been studied in two completed clinical trials. NCT03001297 was a Phase 1 single-dose study in healthy volunteers, and NCT03351738 was a Phase 2 study in adults with stable coronary heart disease. Both trials were conducted in the United States.

Is MEDI5884 FDA approved?

MEDI5884 is not FDA approved. It is an investigational drug that has completed Phase 1 and Phase 2 clinical trials, but it remains in clinical development. No approval status has been granted, and further studies may be needed to establish its safety and efficacy.