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M5542

Phase 1

Healthy | Monoclonal antibody | Other |Merck KGaA|Last Updated: Aug 20, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment49

FDA Designations

No designations recorded

Clinical trial landscape

M5542 · 1 trial · 1 indication

Phase 1 1
NCT06577337Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy ParticipantsHealthy
RECRUITING49 Analytics
PHASE1RECRUITING
Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants
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Study Endpoints

Primary Endpoints

Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Up to Day 85
Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Up to Day 85

Secondary Endpoints

Pharmacokinetic (PK) Serum Concentrations of M5542
Pre-dose up to 1344 hours post-dose
Number of Participants with Anti-Drug Antibodies (ADA) Against M5542
Pre-dose up to Day 57
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeOTHER

Treatment Arms

ArmTypeDescription
M5542EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
M5542BIOLOGICALParticipants will receive a single ascending dose of M5542 subcutaneously on Day 1.
PlaceboBIOLOGICALParticipants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants are overtly healthy, as determined by medical evaluation, by physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection, or disease that would pose a risk to participant safety or interfere with the study eval...

Countries:Germany
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT06577337lastUpdatePostDate: changed
LOWAug 20, 2026NCT06577337lastUpdatePostDate: changed
LOWJul 8, 2026NCT06577337primaryCompletionDate: changed
LOWJul 8, 2026NCT06577337primaryCompletionDate: changed

Frequently asked questions about M5542

What is M5542?

M5542 is an investigational monoclonal antibody being developed by Merck KGaA. It is currently in Phase 1 clinical development for use in healthy participants. The drug is being studied in a single ascending dose trial to evaluate its safety and tolerability.

What does M5542 target?

M5542 is a monoclonal antibody, but its specific molecular target has not been disclosed. The drug is being evaluated in a Phase 1 trial in healthy participants to assess its safety and pharmacokinetics.

Who makes M5542?

M5542 is being developed by Merck KGaA, a science and technology company. The company's stock is traded under the ticker MKGAF. The drug is currently in Phase 1 clinical development.

What phase is M5542 in?

M5542 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 trial is currently recruiting participants to study single ascending doses of the drug.

What clinical trials is M5542 in?

M5542 is being studied in a Phase 1 clinical trial with the identifier NCT06577337. This trial is a single ascending dose study in healthy participants, with an enrollment of 49. The trial is recruiting in Germany and is placebo-controlled and double-blinded.

Is M5542 FDA approved?

M5542 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The drug is being studied in a clinical trial to evaluate its safety and tolerability in healthy participants.