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

NCT02571569 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-10-18

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

DRUG

BAY1093884

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

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-28
Primary Completion
2018-07-09
Completion
2018-10-11
FDA Drug
Yes

Countries

  • Bulgaria
  • Germany
  • Japan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02571569 on ClinicalTrials.gov