Multiple Ascending Dose Study in Healthy Subjects

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2019
This study is a Phase 1, randomized, double‐blind, placebo‐controlled, multiple dose, dose escalation safety, tolerability and PK study of NPT189 in healthy subjects. Three dose cohorts are planned each with a maximum of 8 subjects (6 active: 2 placebo) enrolled per cohort. Eligible subjects will be administered NPT189 by IV infusions at the dose specified for their cohort (i.e., 2 mg/kg, 5 mg/kg, and 12.5 mg/kg) or a matching placebo. Subjects will receive a total of 5 doses of NPT189, with doses administered at weekly intervals. Safety and tolerability will be assessed by analysis of adverse events (AEs), vital signs, electrocardiograms (ECG), laboratory and physical examinations. PK will be assessed by analysis of serum NPT189 concentrations.
Epistemonikos ID: 3c47b1417c6fba75fb3b3b47a61b148827cb6bea
First added on: May 22, 2024