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

NCT01958645 | Completed Phase 1 Results

• 1 other identifier: D5050C00001
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

Phase 1, healthy male subjects, safety and tolerability, pharmacodynamic, pharmacokinetic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline Endogenous Thrombin Potential (ETP)

  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

Study Arms (2)

A

EXPERIMENTAL

MEDI8111

Drug: MEDI8111

B

PLACEBO COMPARATOR

Placebo for MEDI8111

Other: Placebo

Interventions

MEDI8111 DRUG

MEDI8111 lyophilisate for solution for infusion

A

Placebo OTHER

Placebo for MEDI8111 saline solution for infusion

B

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

London, United Kingdom

Location

Limitations and Caveats

Limitations: few subjects, high variability of coagulation variables

Results Point of Contact

• Title: Anders Berggren, MD, PhD
• Organization: AstraZeneca

clinicaltrialtransparency@astrazeneca.com

Study Officials

• Karin Wahlander, MD

  AstraZeneca Mölndal, Sweden

  STUDY DIRECTOR

• Anders Berggren, MD

  AstraZeneca Mölndal, Sweden

  STUDY CHAIR

• Timothy Mant, Prof

  Quintiles London, United Kingdom

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 4, 2016
• Results First Posted: February 4, 2016

Record last verified: 2015-12

Locations

GB (1)