Safety, Tolerability and Pharmacokinetic Profiles of MOTREM (LR12) in Healthy Male Subjects

A Phase I, Randomised, Placebo Controlled Study to Assess the Safety, Tolerability and Pharmacokinetic Profiles of Ascending, Single, Intravenous Doses of MOTREM (LR12) in Healthy Male Subjects

This was a single center, randomized, placebo-controlled study with a sequential i.v. dose escalation cohorts design, to assess safety, tolerability and pharmacokinetics of MOTREM (nangibotide) in healthy volunteers

This was a dose escalation study in healthy volunteers to evaluate the safety and pharmacokinetics of nangibotide in humans

Inclusion Criteria:

• healthy male
• ≥18 to ≤45 years old
• Body mass index (BMI) between 18-30 kg/m² inclusive
• Written informed consent to participate.

Main Exclusion Criteria:

• Any clinically relevant acute or chronic diseases
• Any history of drug or alcohol abuse
• Any History of clinical significant disease as determined by medical history, physical examination or other evaluations.