2 results
Approved WMOCompleted
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…
Approved WMOCompleted
Primary ObjectiveTo generate evidence demonstrating the domain specification (via modern psychometric methods), reliability, validity, and responsiveness (within-subject meaningful change) of the patient-reported outcome (PRO) endpoints Secondary…