4 results
To provide, or continue to provide, UT-15C SR for eligible subjects who participated in protocols TDE-PH-301 or TDE-PH-302 or TDE-PH-308 or additional UC-15C SR clinical protocols.To assess the long-term safety of UT-15C SR in these subjects through…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 12) in subjects with PAH who are not currently receiving ERA, PDE-5…
Phase 1b Dose Escalation Objectives • To determine the safety and tolerability of escalating doses of GB5121• To determine the optimal biological dose (OBD) and/or maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of GB5121 Phase 1b…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…