NCT03676322 is a Phase 1 clinical trial of M5049 in Healthy, sponsored by Merck KGaA, Darmstadt, Germany.

Who is sponsoring NCT03676322?

NCT03676322 is sponsored by Merck KGaA, Darmstadt, Germany.

What drugs are being tested in NCT03676322?

Interventions in NCT03676322: M5049, Placebo.

Is NCT03676322 still recruiting?

NCT03676322 is currently completed. Last updated 3 December 2019.

Last reviewed 2019-12-03 · How we verify

NCT03676322

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

Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study of M5049 in Healthy Participants

Completed Phase 1 Last updated 3 December 2019

What this trial tests

Phase 1 trial testing M5049 in Healthy in 96 participants. Completed in 26 July 2019.

Timeline

20 September 2018

Primary endpoint
26 July 2019

26 July 2019

Quick facts

Lead sponsor	Merck KGaA, Darmstadt, Germany
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	96
Start date	20 September 2018
Primary completion	26 July 2019
Estimated completion	26 July 2019
Sites	1 location across Germany

Drugs / interventions tested

M5049 — full drug profile →
Placebo

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Merck KGaA, Darmstadt, Germany — full company profile →

Who can join

Adults 18 to 45, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study will evaluate the safety, tolerability, Pharmacokinetic (PK), Pharmacodynamics (PD), and explore the food effect of M5049 in healthy male and female participants.

Publications & conference data

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

Phase 1 study in healthy participants of the safety, pharmacokinetics, and pharmacodynamics of enpatoran (M5049), a dual antagonist of toll-like receptors 7 and 8.
Port A, Shaw JV, Klopp-Schulze L, Bytyqi A, et al · · 2021 · cited 39× · PMID 34414672 · DOI 10.1002/prp2.842
Nucleic acid-sensing toll-like receptors: Important players in Sjögren's syndrome.
Alexopoulou L. · · 2022 · cited 14× · PMID 36389822 · DOI 10.3389/fimmu.2022.980400
Applying Modeling and Simulations for Rational Dose Selection of Novel Toll-Like Receptor 7/8 Inhibitor Enpatoran for Indications of High Medical Need.
Klopp-Schulze L, Shaw JV, Dong JQ, Khandelwal A, et al · · 2022 · cited 12× · PMID 35390178 · DOI 10.1002/cpt.2606
Asia-inclusive drug development leveraging principles of ICH E5 and E17 guidelines: Case studies illustrating quantitative clinical pharmacology as a foundational enabler.
Lu H, Klopp-Schulze L, Mukker JK, Li D, et al · · 2024 · cited 2× · PMID 39445632 · DOI 10.1111/cts.70050

Verify or expand the search:

Other trials of M5049

Trials testing the same drug.

NCT04880213 — Study of M5049 in Healthy Japanese and Caucasian Participants · Phase 1 · completed
NCT04647708 — Study of M5049 in CLE and SLE Participants · Phase 1 · completed
NCT04448756 — Study of M5049 in Participants With COVID-19 Pneumonia (ANEMONE) · Phase 2 · completed

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Merck KGaA, Darmstadt, Germany trials

Trials by the same sponsor.

NCT03845140 — L-PZQ ODT in Schistosoma Infected Children · Phase 3 · completed
NCT03858049 — Efficacy and Safety of Crinone Versus Combination Medication (ACCESS) · Phase 4 · terminated
NCT03745144 — Effects of Cladribine Tablets on the PK of Microgynon® · Phase 1 · completed
NCT03717155 — Study of Avelumab and Cetuximab Plus Gemcitabine and Cisplatin in Participants With NSCLC · Phase 2 · completed
NCT03725072 — Human Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Evobrutinib · Phase 1 · completed

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 NCT03676322 (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 Merck KGaA, Darmstadt, Germany
Last refreshed: 3 December 2019

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/NCT03676322.

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