Phase 1
Completed N=12
To Assess Safety, Tolerability and Pharmacodynamics of Intravenous MEDI8111 After Single Ascending Doses.
Healthy Subjects
Source: ClinicalTrials.gov NCT01958645 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination — 2; 3; 2; 1 Participants
Summary
A study to investigate the safety, tolerability and pharmacodynamics of MEDI8111 after single ascending doses in healthy male.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Description of the Safety Profile in Terms of Adverse Events (AE),Vital Signs, ECG, Lab Variables, Immunogenicity and Physical Examination |
2; 3; 2; 1; 1; 1 | — |
| SECONDARY Change From Baseline Endogenous Thrombin Potential (ETP) |
16; 131; NA; NA; 30.5; 145 | — |
| SECONDARY Change From Baseline Factor II Concentrations by ECL Assay |
-0.0810; -0.0188; NA; NA; -0.0480; 0.0275 | — |
| SECONDARY Change From Baseline Factor II Concentrations by Clot Assay |
7.65; -1.40; NA; NA; 3.15; 1.35 | — |
| SECONDARY Change From Baseline D-dimer Concentration |
-0.0169; 0.0408; NA; NA; 0.0432; 0.0383 | — |
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
Data sourced from ClinicalTrials.gov (NCT01958645). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.