NCT03493269 is a Phase 1 clinical trial of BAY1834845 in Healthy Volunteers, sponsored by Bayer.

Who is sponsoring NCT03493269?

NCT03493269 is sponsored by Bayer.

What drugs are being tested in NCT03493269?

Interventions in NCT03493269: BAY1834845, Matching Placebo, Midazolam.

What condition does NCT03493269 study?

NCT03493269 studies Healthy Volunteers, Psoriasis.

Is NCT03493269 still recruiting?

NCT03493269 is currently completed. Last updated 26 February 2021.

Last reviewed 2021-02-26 · How we verify

NCT03493269

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 26 February 2021

What this trial tests

Phase 1 trial testing BAY1834845 in Healthy Volunteers in 72 participants. Completed in 5 February 2021.

Timeline

16 April 2018

Primary endpoint
16 September 2020

5 February 2021

Quick facts

Lead sponsor	Bayer
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	16 April 2018
Primary completion	16 September 2020
Estimated completion	5 February 2021
Sites	2 locations across Germany

Drugs / interventions tested

BAY1834845 — full drug profile →
Matching Placebo — full drug profile →
Midazolam (midazolam) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →
Psoriasis — all drugs for Psoriasis →

Sponsor

Bayer — full company profile →

Who can join

Adults 18 to 70, any sex, with Healthy Volunteers or Psoriasis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Toll-like receptor signalling in B cells during systemic lupus erythematosus.
Fillatreau S, Manfroi B, Dörner T. · · 2021 · cited 229× · PMID 33339987 · DOI 10.1038/s41584-020-00544-4
Small Molecule NF-κB Pathway Inhibitors in Clinic.
Ramadass V, Vaiyapuri T, Tergaonkar V. · · 2020 · cited 154× · PMID 32708302 · DOI 10.3390/ijms21145164
The role of inflammation in autoimmune disease: a therapeutic target.
Xiang Y, Zhang M, Jiang D, Su Q, et al · · 2023 · cited 104× · PMID 37859999 · DOI 10.3389/fimmu.2023.1267091
Oral IRAK4 inhibitor BAY-1834845 prevents acute respiratory distress syndrome.
Li Q, Li R, Yin H, Wang S, et al · · 2022 · cited 14× · PMID 36076574 · DOI 10.1016/j.biopha.2022.113459
Emerging interleukin-1 receptor-associated kinase 4 (IRAK4) inhibitors or degraders as therapeutic agents for autoimmune diseases and cancer.
Feng Y, Chen C, Shao A, Wu L, et al · · 2024 · cited 11× · PMID 39807338 · DOI 10.1016/j.apsb.2024.09.008
Involvement of nucleic acid-sensing toll-like receptors in human diseases and their controlling mechanisms.
Lin YS, Chang YC, Pu TY, Chuang TH, et al · · 2025 · cited 3× · PMID 40495154 · DOI 10.1186/s12929-025-01151-9
Zabedosertib, a novel interleukin-1 receptor-associated kinase-4 inhibitor, shows a favorable pharmacokinetic and safety profile across multiple phase 1 studies.
Feldmüller M, Jodl SJ, Ploeger B, Wagenfeld A, et al · · 2025 · cited 2× · PMID 40520205 · DOI 10.3389/fphar.2025.1521505
Efficacy and Safety of Zabedosertib, an Interleukin-1 Receptor-Associated Kinase 4 Inhibitor, in Patients with Moderate-to-Severe Atopic Dermatitis: A Phase II Randomized Study.
Jodl SJ, Worm M, Friedrichs F, Heinzel-Pleines U, et al · · 2025 · PMID 40906353 · DOI 10.1007/s13555-025-01505-z

Verify or expand the search:

Other trials of BAY1834845

Trials testing the same drug.

NCT05003089 — A Trial to Learn How BAY1834845 and BAY1830839 Affect Inflammation When Taken by Mouth Twice a Day for 7 Days in a Row i · Phase 1 · completed
NCT03244462 — Food Effect, Oral & Intravenous Pharmacokinetics and Absolute Bioavailability of BAY1834845 Including Drug-drug Interact · Phase 1 · completed
NCT03054402 — First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and to Explore Pharmacodynamics of BAY183 · Phase 1 · completed

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Currently open trials in the same condition.

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Other Bayer trials

Trials by the same sponsor.

NCT05900388 — A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolis · not yet recruiting
NCT07490431 — An Observational Study to Learn More About How Elinzanetant is Used and How Well it Works for Women With Menopause Sympt · not yet recruiting
NCT05477953 — An Observational Pregnancy Safety Study in Women Who Were Exposed to the Drug Nifurtimox During Pregnancy to Learn About · not yet recruiting
NCT07192952 — A Study to Learn More About How Safe Finerenone is, When it is Taken for a Longer Time With Standard Treatment, in Child · Phase 3 · not yet recruiting
NCT07450599 — A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Befo · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03493269 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bayer
Last refreshed: 26 February 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03493269.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing