Trials Sponsors Conditions Drugs Pricing

Conditions

Healthy Volunteers Psoriasis

Outcome Measures

Primary Outcomes (12)

Frequency of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Approximately 47 days
Severity of treatment-emergent adverse events (TEAEs)
Part 1 in healthy male subject
Approximately 47 days
Frequency of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Approximately 84 days
Severity of treatment-emergent adverse events (TEAEs)
Part 2: Patients with psoriasis
Approximately 84 days
AUC(0-24)md of BAY1834845
Part 1 AUC(0-24)md: AUC from zero to 24 hours after multiple dosing
Part 1 - Period 1 (dose group 1-4): Day 1 to 2 Part 1 - Period 2 (dose group 5): Day 1 to 2

Study Arms (4)

BAY1834845

EXPERIMENTAL

Part 1 in healthy male subjects: Dose Groups 1-4 : orally administered multiple ascending doses. The treatment will last 10 consecutive days (treatment period1) and 1 day (treatment period 2) Dose Group 5: The treatment will last 1 day (treatment period 1) and 10 consecutive days (treatment period 2)

Drug: BAY1834845Drug: Midazolam

Matching Placebo

PLACEBO COMPARATOR

Part 1: Matching placebo in healthy male subjects.

Other: Matching PlaceboDrug: Midazolam

Chosen dose of BAY1834845

EXPERIMENTAL

Interventions

BAY1834845Drug

Orally administered.

BAY1834845Chosen dose of BAY1834845

Matching PlaceboOther

Orally administered.

Matching PlaceboPlacebo

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Part 1 (healthy male subjects)
Healthy male subjects, 18 to 50 years of age (inclusive), and in good health as determined by medical history, physical examination, vital signs, electrocardiogram (ECG), and laboratory tests at screening

Sponsors & Collaborators

Bayer
Industrylead

Study Sites (2)

Charité Research Organisation GmbH

Berlin, 10117, Germany

PAREXEL GmbH

Berlin, 14050, Germany

Related Publications (1)

Feldmuller M, Jodl SJ, Ploeger B, Wagenfeld A, Wiesinger H, Zollmann FS, Klein S, Zhang R, Rohde B, Hochel J. Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies. Front Pharmacol. 2025 May 30;16:1521505. doi: 10.3389/fphar.2025.1521505. eCollection 2025.
PMID: 40520205DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

zabedosertibMidazolam

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

Bayer Study Director
Bayer
STUDY DIRECTOR

Enrollment

72 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 4, 2018

First Posted

April 10, 2018

Study Start

April 16, 2018

Actual (reported)

A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (12)

Study Arms (4)

BAY1834845

Matching Placebo

Chosen dose of BAY1834845

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (12)

Study Arms (4)

BAY1834845

Matching Placebo

Chosen dose of BAY1834845

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Placebo

You may not qualify if:

Source record

Locations