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Trial record 1 of 1 for:    medi8111
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To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01958645
First received: October 7, 2013
Last updated: January 5, 2016
Last verified: December 2015
  Purpose
A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.

Condition Intervention Phase
Healthy Subjects Drug: MEDI8111 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination [ Time Frame: From screening and up to the lab follow-up visit (Day 29) ]

Secondary Outcome Measures:
  • Change From Baseline Endogenous Thrombin Potential (ETP) [ Time Frame: 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 [ Time Frame: Predose and 1-8 hours ]
  • Change From Baseline Factor II Concentrations by Clot Assay [ Time Frame: Predose and 1-8 hours ]
  • Change From Baseline D-dimer Concentration [ Time Frame: predose and 1-8 hours ]

Enrollment: 157
Study Start Date: November 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958645

Locations
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
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
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01958645     History of Changes
Other Study ID Numbers: D5050C00001
Study First Received: October 7, 2013
Results First Received: October 22, 2015
Last Updated: January 5, 2016

Keywords provided by AstraZeneca:
Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic

ClinicalTrials.gov processed this record on August 22, 2017