Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers

A Phase I, Randomized, Double-blind, Parallel Group and Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab in Response to Single Ascending Intravenous Infusion Doses.

This is a double-blind, parallel group and placebo-controlled clinical study to assess safety tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers

Inclusion Criteria:

• healthy male subjects
• body mass index 18-32 kg/m2
• normal physical examination, clinical laboratory values and ECG
• additional inclusion criteria apply

Exclusion Criteria:

• febrile or infectious illness at least 7 days prior to the first administration
• any active physical disease, acute or chronic
• history of alcohol or drug abuse
• history of chronic or recurrent metabolic, renal, hepatic, pulmonary, gastrointestinal, neurological, endocrinological, immunological, psychiatric, or cardio-vascular disease, myopathies and bleeding tendency
• additional exclusion criteria apply