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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
49
Clinical Pharmacology Unit of Nuvisan GmbH
Neu-Ulm, Germany
RECRUITINGNumber of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 85
Number of Participants with Abnormal Laboratory Assessments, 12-Lead Electrocardiogram (ECG), and Vital Signs
Time frame: Up to Day 85
Pharmacokinetic (PK) Serum Concentrations of M5542
Time frame: Pre-dose up to 1344 hours post-dose
Number of Participants with Anti-Drug Antibodies (ADA) Against M5542
Time frame: Pre-dose up to Day 57
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.