Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group, placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects.

Multiple dose escalation study in a multicenter, randomized, single-blind, parallel-group, placebo-controlled design to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of BAY 1213790 administered subcutaneously in healthy male subjects. - Multiple dose escalation study of BAY 1213790.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46278

Enrollment

Registered

2018-09-06

Start date

2019-04-12

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Veneuze trombo-embolie. Venous thromboembolism

Interventions

Group 1 Day 1

BAY 1213790 100 mg or placebo once Group 1 Day 29, 57, 85

BAY 1213790 35 mg or placebo once per dosing day Group 2 Day 1

BAY 1213790 200 mg or placebo once Group 2 Day 29, 57, 85

BAY 1213790 70 mg or placebo once per dosing day

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: white healthy male 18 - 55 years weight less then 115 kilograms BMI 18 - 29.9 kilograms/meter2

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study. Donation of more than 100 mL of whole blood or plasma within 4 weeks or 500 mL whole blood within 3 months before study drug administration.

Design outcomes

Primary

Measure	Time frame
To investigate the safety and tolerability of BAY 1213790 administered subcutaneously as a single loading dose followed by multiple maintenance doses in healthy male subjects by means of frequency of TEAEs.	—

Secondary

Measure	Time frame
To investigate the PK of BAY 1213790 in plasma after multiple subcutaneous doses	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)