The randomised, double-blind, placebo-controlled, dose escalation study will be conducted at one centre in the US and is designed to enroll 65 subjects in eight dose cohorts.
The primary objective of the study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending intravenous doses of CTLA4-Ig therapeutic in healthy male and female subjects.
The secondary objective of the study is to evaluate the pharmacodynamics of the CTLA4-Ig therapeutic.
CTLA4-Ig therapeutic is being developed by Perseid Therapeutics, Maxygen’s majority-owned subsidiary, in partnership with Astellas Pharma – which is sponsoring the clinical trial.