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

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Other: Placebo; Drug: MEDI8111

• Registration Number: NCT01958645
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-07
• Study First Posted: 2013-10-09
• Study Start: 2013-11
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2015-10-22
• Status Verified: 2015-12
• Results First Submitted QC: 2016-01-05
• Last Update Submitted: 2016-01-05
• Results First Posted: 2016-02-04
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	Placebo for MEDI8111
A	MEDI8111	MEDI8111

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline Endogenous Thrombin Potential (ETP)	Predose and Days 1-5	For the baseline variables and adverse events the two placebo arms (placebo dose 1 and placebo dose 2) are recorded as one. For the secondary outcome measures the two placebo arms are recorded separately.
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
Change From Baseline D-dimer Concentration	predose and 1-8 hours

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom