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

Study Purpose

To assess safety and tolerability of multiple oral doses of BAY1834845 in healthy male subjects (Part 1) and in patients with psoriasis (Part 2). To assess the pharmacokinetic (PK) properties of total BAY1834845 in plasma after oral multiple doses of BAY1834845 in healthy male subjects (Part 1) and patients with psoriasis (Part 2).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

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 - Body mass index (BMI) above or equal to 18.5 and lower or equal to 30 kg/m2 (BMI = body weight (kg) / [height (m)]2 and a body weight above or equal 50 kg Part 2 (patients with psoriasis) - Male patients, 18 to 70 years of age (inclusive) or female patients of non-child bearing potential, 30 to 70 years of age (inclusive) - Body mass index above or equal to 18.5 and lower or equal to 35 kg/m*2 and a body weight above 50 kg - A documented diagnosis of psoriasis, with a history of at least 6 months prior to study drug administration.
Moderate to severe plaque psoriasis at screening, defined by: a) an involved body surface area (BSA) above or equal to 10% of BSA, b) a Psoriasis Area and Severity Index (PASI) score of above or equal, 12 c) a Physician's Global Assessment (PGA) score of above or equal 2.

Exclusion Criteria:

- History of hypersensitivity to any of the components of the study drug - Any clinically relevant abnormal findings in safety laboratory parameters and ECG - History of tuberculosis (TB) or active or latent tuberculosis - Receipt of live or attenuated vaccine 90 days prior to the first dosing

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Bayer Study Director
Principal Investigator Affiliation Bayer
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Overall Status Recruiting
Countries Germany

The disease, disorder, syndrome, illness, or injury that is being studied.

Healthy Volunteers, Psoriasis
Arms & Interventions


Experimental: BAY1834845

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)

Placebo Comparator: Matching Placebo

Part 1: Matching placebo in healthy male subjects.

Experimental: Chosen dose of BAY1834845

Part 2: This dose level will be adminstered in female and male patients with psoriasis

Placebo Comparator: Placebo

Part 2: The placebo will be adminstered in female and male patients with psoriasis


Drug: - BAY1834845

Orally administered.

Other: - Matching Placebo

Orally administered.

Drug: - Midazolam

Part 1: Orally administered 1mg as a single dose.

Contact a Trial Team

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International Sites

Charité Research Organisation GmbH, Berlin, Germany




Charité Research Organisation GmbH

Berlin, , 10117

PAREXEL GmbH, Berlin, Germany





Berlin, , 14050

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