3 results
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…
Primary Objective* To describe the antitumour efficacy of LAN monotherapy plus BSC every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria,…
Primary Objective: Proof of safety and tolerability of home parenteral nutrition (HPN) with an Omega-3 fatty acid enriched MCT/LCT lipid emulsion in adult patients with chronic intestinal failure (CIF) in need of long-term HPNSecondary Objectives:…