17 results
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…
The objectives are to evaluate the safety and efficacy of TRC4186 and to define the recommended dose level for further pivotal studies.
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…
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,…
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…
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
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…
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…
Primary objective:To evaluate the efficacy of soraprazan in reducing the amount of lipofuscin inRPE cells of subjects with Stargardt disease by assessing the change inquantitative auto-fluorescence (qAF8) from baseline to after treatment…
The primary objective of this study is to evaluate the inhibition of PACAP-38 induced migraine-like attacks by AMG 334Secondary objectives:* To evaluate the inhibition of PACAP-38 induced headaches by AMG 334* To evaluate the safety, tolerability,…
The aim of this study is to evaluate the efficacy, safety and tolerability of BI 1015550 9 mg BID and 18 mg BID compared to placebo in patients with PF-ILD, in addition to the patient's standard of care. The primary objective of this study is…
The objective of this study is to investigate the mechanism(s) of action of tirzepatide in the kidney, in participants who are overweight or living with obesity and coexisting CKD, with and without T2D, to inform potential future kidney outcomes…
To characterize the safety and tolerability of ascending single oral doses (part A) and ascending repeated oral doses (part B) of GM-1020 and the effect of food on single dose GM-1020 (part C) in healthy volunteers.
Part 1; Single ascending dose (main objective)• To investigate the safety and tolerability of single oral doses of VRG50635 in healthy adult subjectsPart 1; Single ascending dose (secondary objective)• To characterize the plasma and urine…
The aim of this study is to evaluate the efficacy, safety and tolerability of BI 1015550 9 mg BID and 18 mg BID compared to placebo in patients with IPF, in addition to the patient's standard of care. The primary objective of this study is to…
To characterize the safety and tolerability of single intravenous (IV) doses (Part A) and intramuscular (IM) doses (Part B) of GM-2505 in healthy volunteers.