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(21751) First-in-human single dose escalation study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of BAY 3018250 in healthy men in a randomized, placebo-controlled, single-blind, group-comparison design

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500505-41-00
Acronym
21751
Enrollment
40
Registered
2022-10-11
Start date
2022-11-08
Completion date
2023-05-12
Last updated
2022-12-20

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

Conditions

Acute ischemic stroke

Brief summary

Number of participants who experienced treatment-emergent adverse events(TEAEs) and drug-related TEAEs after administration of BAY3018250

Detailed description

Cmax and Cmax/D of BAY3018250, AUC and AUC/D of BAY3018250 (if AUC cannot be determined reliably in all participants, AUC(0-t) will be used instead)

Interventions

DRUGBAY 3018250
DRUGPlacebo equals test product
DRUGexcept active substance

Sponsors

Bayer AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
Male
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Number of participants who experienced treatment-emergent adverse events(TEAEs) and drug-related TEAEs after administration of BAY3018250—

Secondary

MeasureTime frame
Cmax and Cmax/D of BAY3018250, AUC and AUC/D of BAY3018250 (if AUC cannot be determined reliably in all participants, AUC(0-t) will be used instead)—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026