4 results
Primary objective:To assess the safety, tolerability and pharmacokinetics of a single IV dosages of OTL-038. Selected doses of OTL-038 will be studied in the absence and presence of prophylactic treatment with the antihistamine clemastine to be…
Primairy objective:• To determine the safety, tolerability and pharmacokinetics of 2B3-201, and in comparison to free methylprednisolone hemisuccinate and placebo;Secundairy objective:• To determine the pharmacodynamic effects of 2B3-201 on CNS…
Main Objective: To assess the effects of OCA in patients with PBC on: -Serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint -SafetySecondary Objectives:To assess the effects of OCA in patients with PBC on:-…
The study includes 2 periods, Period 1 and Period 2. Subjects will participate in both periods. Period 1:The purpose of Period 1 is to investigate how quickly and to what extent enpatoran is absorbed, transported and eliminated from the body (this…