5 results
Primary objectives:1) To evaluate the safety and tolerability of multiple doses GAL-021 in healthy volunteers.2) To evaluate the pharmacokinetic profile of multiple doses of GAL-021 in healthy volunteers.3) To evaluate the pharmacodynamic effects at…
PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…
The primary objective is to investigate the efficacy of a single intradiscal injection of STA363 into one or two IVDs as compared to placebo by the following primary efficacy endpoint:* Change from baseline at Month 6 in mean pain intensity measured…
Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…
Escalation PhasePrimary ObjectivesThe primary objectives of this study are to:• Determine the safety and tolerability of oral DCC-2618• Determine a maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of oral DCC-261Secondary…