Clinical trial NCT06577337: Single and Multiple Ascending Doses of M5542 Administered in Healthy Volunteers
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Single and Multiple Ascending Doses of M5542 Administered Subcutaneously in Healthy Participants
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2024-08-29
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The study will evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK) of single ascending doses (SAD) and multiple ascending doses (MAD) of M5542 in healthy participants. This study will be conducted in 2 parts: Part A (SAD) and Part B (MAD).


Eligibility 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

Primary outcomes:
measure: Part A: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 85
measure: Part B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Day 113
measure: Part A: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
timeFrame: Up to Day 85
measure: Part B: Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
timeFrame: Up to Day 113
Secondary outcomes:
measure: Part A and Part B: Pharmacokinetic (PK) Serum Concentrations of M5542
timeFrame: Part A: Pre-dose up to 1344 hours post-dose; Part B: Pre-dose up to 2688 hours post-dose
measure: Part A and B: Number of Participants with Anti-Drug Antibodies (ADA) Against M5542
timeFrame: Part A: Pre-dose up to Day 57; Part B: Pre-dose up to Day 113
Other outcomes:
Locations:
city: Neu-Ulm
country: Germany
facility: Clinical Pharmacology Unit of Nuvisan GmbH
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: