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A Multiple Dose Study of BAY1834845 in Healthy Male Subjects and in Patients With Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Exploratory Pharmacodynamics of Multiple Oral Doses of BAY1834845 in Healthy Male Subjects and in Female and Male Patients With Psoriasis Over an Extended Treatment Duration

NCT03493269•Bayer

View on ClinicalTrials.gov

Summary

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).

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (2)

Charité Research Organisation GmbH

Berlin, Germany

PAREXEL GmbH

Berlin, Germany

Key Dates

Start Date

April 16, 2018

Primary Completion Date

September 16, 2020

Completion Date

February 5, 2021

Last Updated

February 26, 2021

Enrollment

ACTUAL participants

Conditions

Healthy VolunteersPsoriasis

Interventions

BAY1834845

DRUG

Matching Placebo

OTHER

Midazolam

DRUG

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Healthy Volunteers (HV)Parkinson's Disease (PD)

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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 26, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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A Study of Guselkumab After Switching From Ustekinumab in Participants With Moderate to Severe Psoriasis

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)