Trials / Completed
CompletedNCT02571569
A Single Escalating Dose and Multiple Dose Study of BAY 1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors
A Phase 1, First in Man, Multicenter, Open Label, Single Escalating Dose Study of BAY1093884 in Subjects With Severe Hemophilia Types A or B, With or Without Inhibitors
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2015-10-28
- Primary completion
- 2018-07-09
- Completion
- 2018-10-11
- First posted
- 2015-10-08
- Last updated
- 2018-10-18
Locations
10 sites across 5 countries: Bulgaria, Germany, Japan, Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02571569. Inclusion in this directory is not an endorsement.