A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-28

Study Completion Date

2018-10-11

Brief Summary

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Investigate the safety, tolerability and pharmacokinetics of BAY1093884 after Intravenous (IV) and subcutaneous (SC) administration of increasing single doses and SC administration of multiple doses.

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Detailed Description

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Conditions

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Hemophilia A Hemophilia B

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Without inhibitors

Dose escalation steps for participants without inhibitors - intravenous infusion and subcutaneous injection

Group Type EXPERIMENTAL

BAY1093884

Intervention Type DRUG

Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined.

With inhibitors

Dose escalation steps for participants with inhibitors - intravenous infusion and subcutaneous injection

Group Type EXPERIMENTAL

BAY1093884

Intervention Type DRUG

Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined.

Without inhibitors_multiple dose

Multiple dose cohort for participants without inhibitors - a single subcutaneous injection once a week for 6 weeks

Group Type EXPERIMENTAL

BAY1093884

Intervention Type DRUG

Multiple dose cohort with a single 150-mg SC injection once a week for 6 weeks.

Interventions

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BAY1093884

Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined.

Intervention Type DRUG

BAY1093884

Multiple dose cohort with a single 150-mg SC injection once a week for 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Males with severe congenital Hemophilia A or B defined as \<1% FVIII or Factor IX (FIX) concentration by measurement at the time of screening or from reliable prior documentation
* For subjects in Cohorts I-IV, I-SC1 and I-SC2; If history of inhibitors is evident, inhibitor titer of ≥5 Bethesda Units (BU) at screening or prior to screening at any time from medical records.
* Age: 18 to 65 years of age at screening
* Body mass index (BMI): 18 to 29.9 kg/m²

Exclusion Criteria

* Subjects with known bleeding disorders (such as von Willebrand factor \[vWF\] deficiency, FXI deficiency, platelet disorders, or known acquired or inherited thrombophilia etc.) other than congenital Hemophilia A or B with or without inhibitors
* History of angina pectoris or treatment for angina pectoris
* History of coronary and/or peripheral atherosclerotic disease, congestive heart failure, disseminated intravascular coagulopathy, or stage 2 hypertension defined as systolic blood pressure (SBP) ≥160 mmHg or diastolic blood pressure (DBP) ≥100 mmHg even if controlled
* History of thrombophlebitis, venous / arterial thromboembolic diseases (particularly deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, cerebrovascular accident, ischemic heart disease, transient ischemic attack)
* Known or suspected hypersensitivity of the immune system, history of anaphylactic reaction, known (clinically relevant) allergies, non-allergic drug reactions, or multiple drug allergies

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No