4 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 Objective1. To evaluate the safety and tolerability of long-term dosing of losmapimod tablets in subjects with FSHD1Secondary Objectives1. To assess target engagement of losmapimod tablets in blood and skeletal muscle over long term dosing2…
Primary Objective:Part A:To evaluate the efficacy of losmapimod for the treatment of FSHD by demonstrating slowing of disease progression assessed by reachable workspace quantification of total relative surface area (RSA) Q1-Q5 with 500 g wrist…
Primary Objectives:• To assess the safety and tolerability of DCC 3014.• To characterize the pharmacokinetic (PK) profile of DCC 3014.• To determine the maximum tolerated dose (MTD) of DCC 3014.• To determine the recommended Phase 2 dose (RP2D) of…