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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: MEDI8111; Other: Placebo

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 Type: Interventional
• Enrollment (Actual): 157
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A; MEDI8111	Drug: MEDI8111; MEDI8111 lyophilisate for solution for infusion
Placebo Comparator: B; Placebo for MEDI8111	Other: Placebo; Placebo for MEDI8111 saline solution for infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Change From Baseline Endogenous Thrombin Potential (ETP)	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.	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
Change From Baseline D-dimer Concentration		predose and 1-8 hours

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Karin Wahlander, MD, AstraZeneca Mölndal, Sweden; Study Chair: Anders Berggren, MD, AstraZeneca Mölndal, Sweden; Principal Investigator: Timothy Mant, Prof, Quintiles London, United Kingdom

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: October 7, 2013
• First Submitted That Met QC Criteria: October 7, 2013
• First Posted (Estimate): October 9, 2013

Study Record Updates

• Last Update Posted (Estimate): February 4, 2016
• Last Update Submitted That Met QC Criteria: January 5, 2016
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
• Other Study ID Numbers: D5050C00001