CClinicalTrials.gg
RecruitingNCT06577337Updated Sep 21, 2026

Phase 1 Single Ascending Doses (SAD) of M5542 in Healthy Participants

A Phase 1 interventional study of M5542 and Placebo in Healthy, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Recruiting at 1 site in Germany. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Other

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

The present study in healthy participants will assess the safety, tolerability, immunogenicity, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) of subcutaneously administered M5542.

02

Conditions studied

  • Healthy

Keywords

  • First-in-Human
03

In context

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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 evaluation, procedures, or completion at Screening and Day -1
  • Participants have a body weight within the range 50 to 100 kilograms (kg) (inclusive) and body mass index (BMI) within the range 18 to 30.0 kilograms per square meter kg/m\^2 (inclusive) at Screening
  • Other protocol defined inclusion criteria could apply

Exclusion criteria

Exclusion Criteria:

  • History or presence of clinically relevant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, musculoskeletal, genitourinary, immunological, dermatological, connective tissue, psychiatric and other diseases or disorders, and epilepsy, as determined by medical evaluation at Screening and Day -1
  • Any condition, including findings in the laboratory tests or other screening assessments, that in the opinion of the Investigator constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study's objectives, conduct, or evaluation at Screening and on Day -1
  • History of any malignancy
  • History of chronic or recurrent acute infection or any bacterial, viral, parasitic, or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening
  • Immunization with any live vaccine for 12 weeks and subunit or inactivated vaccines for 2 weeks prior to dosing on Day 1. For the herpes zoster vaccine (e.g. Shingrix), if the first dose is administered at least 2 weeks prior to Day 1, the second dose must be administered after the study treatment period has been completed
  • Other protocol defined exclusion criteria could apply
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
49 participants (estimated)

Study arms

  • Experimental
    M5542

    Biological: M5542

  • Placebo comparator
    Placebo

    Biological: Placebo

Interventions

  • BiologicalM5542

    Participants will receive a single ascending dose of M5542 subcutaneously on Day 1.

  • BiologicalPlacebo

    Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1.

06

What researchers measure

Primary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 85

  2. Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs

    Time frame: Up to Day 85

Secondary outcomes

  1. Pharmacokinetic (PK) Serum Concentrations of M5542

    Time frame: Pre-dose up to 1344 hours post-dose

  2. Number of Participants with Anti-Drug Antibodies (ADA) Against M5542

    Time frame: Pre-dose up to Day 57

07

Study locations

1 of 1 sites recruiting
  • Clinical Pharmacology Unit of Nuvisan GmbH
    Neu-Ulm, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — IPD will not be shared for Phase I interventional or observational studies. Further information on how to request data can be found on our website bit.ly/IPD21.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06577337
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Sep 12, 2024
Primary completion
Nov 16, 2026 (estimated)
Completion
Mar 18, 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Communication Center
Contact
service@emdgroup.com
+49 6151 72 5200
Medical Responsible
study director · Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion