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MEDI8111

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Feb 4, 2016

MEDI8111 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Oct 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment157

FDA Designations

No designations recorded

MEDI8111 clinical trials

MEDI8111 · 1 trial · 1 indication

Phase 1 1
NCT01958645To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.Healthy Subjects
COMPLETED157 Analytics
PHASE1COMPLETED
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
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Study Endpoints

Primary Endpoints

Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
From screening and up to the lab follow-up visit (Day 29)

Secondary Endpoints

Change From Baseline Endogenous Thrombin Potential (ETP)
Predose and Days 1-5
Change From Baseline Factor II Concentrations by ECL Assay
Predose and 1-8 hours
Change From Baseline Factor II Concentrations by Clot Assay
Predose and 1-8 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
AEXPERIMENTALMEDI8111
BPLACEBO_COMPARATORPlacebo for MEDI8111

Interventions

NameTypeDescription
MEDI8111DRUGMEDI8111 lyophilisate for solution for infusion
PlaceboOTHERPlacebo for MEDI8111 saline solution for infusion
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Provision of signed and dated, written informed consent prior to any study specific procedures, Healthy male subjects aged 18-40 years with suitable veins for cannulation or repeated venepuncture, Have a body mass index (BMI) between 18 and 30 kg/m2 inclusive and weight at lea...

Countries:United Kingdom
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Frequently asked questions about MEDI8111

What is MEDI8111?

MEDI8111 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult male subjects in the United Kingdom. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who is developing MEDI8111?

MEDI8111 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 study of the compound conducted in the United Kingdom.

What phase is MEDI8111 in?

MEDI8111 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. It is an investigational agent and has not been approved by the FDA for any indication.

What clinical trials has MEDI8111 been studied in?

MEDI8111 was evaluated in a single Phase 1 trial, NCT01958645, titled a study to assess safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses. The trial enrolled 157 healthy male subjects in the United Kingdom and has been completed.

How was the MEDI8111 Phase 1 trial designed?

The Phase 1 trial NCT01958645 was a randomized, placebo-controlled study of intravenous MEDI8111 given as single ascending doses. It enrolled 157 healthy male volunteers aged 18 years and older in the United Kingdom. The study was not double-blind and has been completed.