44 results
The primary objective in the study is to explore the effect of three different amplitude settings (50%…
Primary Objective- To evaluate the safety and tolerability of AP30663 in healthy malesSecondary Objectives- To evaluate the pharmacokinetic profile of AP30663.Exploratory Objectives- To evaluate the effect of AP30663 on electrocardiographical…
Primary Objectives:* Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D, 200mg BID) of TAS-119.
Primary goal is the evaluation of the safety and tolerability of MMMAE-anti-CD79b-conjugate administered every 3 weeks. The maximal tolerated dose and the dose-limiting toxicity are the important parameters. Based on these data, the dose of MMAE-…
• To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects with LCA or RP caused by RPE65 or LRAT gene mutations who have been treated previously with a single 7-day course of QLT091001 in…
Primary objectives: To assess the feasibility of ZW800-1 in intraoperative detection of the urinary tract using the NIR fluorescence imaging system. Secondary objectives: To define the optimal dose of ZW800-1 for intraoperative imaging of the…
Part 1:Primary Objective- To assess the safety and tolerability of SBT-020 in early stage HD patients. Secondary Objective- To investigate the effect of SBT-020 on mitochondrial function, measured by dynamic 31P-MRS in calf muscles of early stage HD…
The primary objective is to assess the effect a resuscitation strategy using balanced solutions versus unbalanced solutions on regional and microvascular perfusion relative to global hemodynamics in intensive care patients following elective cardiac…
Primary objective:- To determine the effect of LIK066 on Liver Function test after 12 weeks of treatmentSecondary objectives: - To determine the effect of LIK066 on intrahepatic lipid after 12 weeks of treatment- To determine the effect of LIK066 on…
Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…
Primary objective:* To determine the safety, tolerability, dose-limiting toxicities (DLT), maximum acceptable dose (MAD) and maximum tolerated dose (MTD) of CHR-2845 when administered orally to patients with advanced or treatment refractory…
Primary:To evaluate the effects of 15 mg E4/3 mg DRSP, of 30 mcg EE/150 mcg LNG, and of 20 mcg EE/3 mg DRSP on hemostasis, endocrine function and lipid and carbohydrate metabolism parameters during 6 treatment cycles.Secondary:To assess the safety…
The objectives of the study are to assess the safety and tolerability of ascending doses of SAR422459 in patients with Stargardt macular disease and to evaluate the possible biological activity of SAR422459.
Primary- To evaluate the effects of the 15 mg E4/3 mg DRSP combination and the 20 mcg EE/3 mg DRSP used as reference combination on ovarian function inhibition at Treatment Cycle 1 and Treatment Cycle 3.Secondary- To evaluate levels of luteinizing…
The primary objectives of this study are:•To explore the antiviral efficacy of combination therapy with SOF/LDV FDC + RBV for12 or 24 weeks in subjects with advanced liver disease (either pre-liver transplant or notcurrently wait-listed) and post-…
Evaluation of the histologically proven adenoma or carcinoma detection rate in patients undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with 200 mg of Methylene Blue MMX® tablets. The lack of mucosal contrast,…
We propose a phase II study (intervention) in patients with severe generalized recessive dystrophic EB receiving reduced toxicity conditioning chemotherapy followe by cord blood transplantation with co-infusion of mesenchymal stromal cell units.…
2.1 Primary Objectives• Evaluate the safety and tolerability of 2 fixed doses of FRM-0334 (300 and 500 mg daily in 2 sequential periods) over 28 days in subjects with prodromal to moderate FTD-GRN• Assess the PD effects of FRM-0334 on the change…
This study will evaluate the efficacy and safety of 2.0 mg/kg/week and 2.0 mg/kg/every other week BMN 110 in patients with mucopolysaccharidosis IVA (Morquio A Syndrome). This study will compare the effects of 24 weeks of infusions of BMN 110 at…
The purpose of the study is to investigate to what extent blood concentrations of Fluticasone Furoate increase proportionately to rising doses of Fluticasone Furoate in three steps administered via a powder inhalator. In addition, the absolute…