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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513069-37-00 | Other Identifier | EU CT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| M5542 | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| M5542 | Biological | Participants will receive a single ascending dose of M5542 subcutaneously on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Contact | +49 6151 72 5200 | service@emdgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit of Nuvisan GmbH | Recruiting | Neu-Ulm | Germany |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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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.
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| Placebo | Biological | Participants will receive a single dose of placebo matched to M5542 subcutaneously on Day 1. |
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