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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

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

To assess safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses.

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.

MEDI8111 lyophilisate for solution for infusion

Placebo for MEDI8111 saline solution for infusion

Research Site

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

Age Continuous

Gender, Male/Female

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Limitations: few subjects, high variability of coagulation variables

Subjects with any AE

Gastrointestinal disorders

Infections and infestations

Investigations

Musculoskeletal and connective tissue disorders

Nervous system disorder

Respiratory, thoracic and mediastinal disorders

Skin and subcutaneous tissue disorders

Description of the safety profile in terms of adverse events (AE),vital signs, ECG, lab variables, immunogenicity and physical examination 

0.98 h

1.03 h

1.25 h

1.5 h

12 h

24 h

36 h

48 h

72 h

96 h

Follow up

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.

Change from baseline endogenous thrombin potential (ETP)

0.33 h

0.67 h

Change from baseline Factor II concentrations by ECL assay

1.25 Change from baseline factor II concentrations by clot assay

Change from baseline D-dimer concentration

Overall Study

The study was prematurely terminated after 2 cohorts as dose escalation stopping criteria (PD thresholds) were reached and it was judged to be of limited value to expose more healthy subjects.
Cohort 1: 2 placebo + 4 MEDI8111 dose 1. 
Cohort 2: 2 placebo + 4 MEDI8111 dose 2.


Arms	Assigned Interventions
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

To assess safety, tolerability and pharmacodynamics of intravenous MEDI8111 after single ascending doses.

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator