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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01958645
• Other study ID #: D5050C00001
• Status: Completed
• Phase: Phase 1
• First received: October 7, 2013
• Last updated: January 5, 2016
• Start date: November 2013
• Est. completion date: October 2014

Study information

• Verified date: December 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare product Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• MEDI8111
MEDI8111 lyophilisate for solution for infusion

Other:
• Placebo
Placebo for MEDI8111 saline solution for infusion

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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	No
Secondary	Change From Baseline Factor II Concentrations by ECL Assay		Predose and 1-8 hours	No
Secondary	Change From Baseline Factor II Concentrations by Clot Assay		Predose and 1-8 hours	No
Secondary	Change From Baseline D-dimer Concentration		predose and 1-8 hours	No