To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-10-31

Brief Summary

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A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

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Detailed Description

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A phase I, single-blind, randomised, placebo-controlled, single centre study to investigate the safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses in healthy male subjects.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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A

MEDI8111

Group Type EXPERIMENTAL

MEDI8111

Intervention Type DRUG

MEDI8111 lyophilisate for solution for infusion

B

Placebo for MEDI8111

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo for MEDI8111 saline solution for infusion

Interventions

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MEDI8111

MEDI8111 lyophilisate for solution for infusion

Intervention Type DRUG

Placebo

Placebo for MEDI8111 saline solution for infusion

Intervention Type OTHER

Eligibility Criteria

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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 least 50 kg an no more than 100 kg inclusive, Male subjects should be willing to avoid fathering a child by either true abstinence or the use of two effective means of contraception from the day of dosing until 3 months after dosing with the IP. They should also be willing to use barrier methods from the day of dosing until 3 months after dosing.

Exclusion Criteria

* Prothrombotic mutation such as factor V Leiden, or deficiencies of protein C, protein S, prothrombin, antithrombin or APC, Antibodies to coagulation FII, History or family history of venous or arterial thromboembolic event, and/or myocardial infarction before age of 50 years, ETP level at baseline \>2000nM/min, FII level (by clot) at screening and/or at baseline outside 50-250% of the normal range

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes