3 results
The objective of this exploratory study is to investigate the acid neutralisation action of sodium alginate oral suspension versus placebo liquid, within the stomach and to assess suitability and robustness of the pH monitoring methodology.
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…
PRIMARYTo demonstrate an effect of recAP on 28-day all-cause mortality.SECONDARY1. To investigate the effect of recAP on long-term Major Adverse Kidney Events (MAKE).2. To investigate the effect of recAP on use of organ support, i.e., mechanical…