Single-dose safety testing of M5542 in healthy adults
A Phase 1, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants
The trial will test single increasing subcutaneous doses of the experimental drug M5542 in healthy adults to see how safe it is and how the body processes it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 49 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Industry-sponsored |
| Locations | 1 site (Neu-Ulm) |
| Trial ID | NCT06577337 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human Phase 1 single ascending dose (SAD) trial in healthy volunteers comparing subcutaneous M5542 to placebo. Sequential cohorts will receive increasing single doses with close safety monitoring and blood sampling for pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity. The study will record tolerability and adverse events and use the data to inform dosing for later trials. Participants are screened for good health and must meet weight and BMI limits before dosing.
Who should consider this trial
Good fit: Healthy adults without clinically significant medical conditions, weighing 50–100 kg with a BMI of 18 to 30 kg/m2, and meeting screening criteria are the intended participants.
Not a fit: People with active medical conditions or anyone seeking therapeutic benefit should not expect direct clinical benefit, since this is a healthy-volunteer safety and PK study.
Why it matters
Potential benefit: If successful, the trial could identify safe dose ranges and provide PK/PD and immunogenicity data needed to design later patient trials.
How similar studies have performed: This is a first-in-human SAD for M5542, but SAD designs have been commonly used successfully to define safety and PK for other investigational drugs.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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 vaccine 42 days prior to dosing on Day 1 or planned within 3 months after the last administration of study intervention * Other protocol defined exclusion criteria could apply
Where this trial is running
Neu-Ulm
- Clinical Pharmacology Unit of Nuvisan GmbH — Neu-Ulm, Germany (Recruiting)
Study contacts
- Study coordinator: Communication Center
- Email: service@emdgroup.com
- Phone: +49 6151 72 5200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.