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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.

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ClinicalTrials.gov Identifier: NCT01958645
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: MEDI8111 Other: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 157 participants
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
Study Start Date : November 2013
Primary Completion Date : October 2014
Study Completion Date : October 2014

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



Primary Outcome Measures :
  1. 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 :
  1. 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.

  2. Change From Baseline Factor II Concentrations by ECL Assay [ Time Frame: Predose and 1-8 hours ]
  3. Change From Baseline Factor II Concentrations by Clot Assay [ Time Frame: Predose and 1-8 hours ]
  4. Change From Baseline D-dimer Concentration [ Time Frame: predose and 1-8 hours ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01958645     History of Changes
Other Study ID Numbers: D5050C00001
First Posted: October 9, 2013    Key Record Dates
Results First Posted: February 4, 2016
Last Update Posted: February 4, 2016
Last Verified: December 2015

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