Clinical trial NCT01958645: To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Keywords: Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-10-09
Enrollment: 157
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination
timeFrame: From screening and up to the lab follow-up visit (Day 29)
Secondary outcomes:
measure: Change From Baseline Endogenous Thrombin Potential (ETP)
timeFrame: Predose and Days 1-5
measure: Change From Baseline Factor II Concentrations by ECL Assay
timeFrame: Predose and 1-8 hours
measure: Change From Baseline Factor II Concentrations by Clot Assay
timeFrame: Predose and 1-8 hours
measure: Change From Baseline D-dimer Concentration
timeFrame: predose and 1-8 hours
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca Mölndal, Sweden
name: Karin Wahlander, MD
role: STUDY_DIRECTOR
affiliation: AstraZeneca Mölndal, Sweden
name: Anders Berggren, MD
role: STUDY_CHAIR
affiliation: Quintiles London, United Kingdom
name: Timothy Mant, Prof
role: PRINCIPAL_INVESTIGATOR
References: