Evaluation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Volunteers
brief summary
ELA026 is a fully human IgG1 SIRP-directed monoclonal antibody designed to reduce the myeloid and T cells driving the inflammation. The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ELA026 in Single and Multiple Doses in Healthy Adults.
detailed description
This is a multi-center, Phase 1, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, PK, and PD of ELA026 following single and multiple IV and/or SC dose administration in healthy adult volunteers, including a subgroup of Japanese volunteers.
The study will consist of 2 parts:
* Part 1: single ascending doses (SAD) in up to 11 SAD cohorts plus a Japanese cohort * Part 2: multiple doses (MD) up to 6 MD cohorts
official title
A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ELA026 Following Intravenous and/or Subcutaneous Administration of Single and Multiple Doses in Healthy Adults