39 results
The objective of the trial is to assess the long-term safety and tolerability of intracerebroventricular administration of sNN0029 infusion solution at a dose of 4 µg/day delivered via a Medtronic SynchroMed® II Infusion System.
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…
Run-in phase I: To confirm the safety and tolerability of BIBF 1120 up to a dose level of 200 mg b.i.d added to a standard dose of cisplatin/gemcitabine in first line NSCLC patients with squamous cell histology. Pharmacokinetics of BIBF 1120 and…
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…
• To evaluate the effect of olaparib on exposure to anastrozole by determination of steady-state exposure to anastrozole in the presence and absence of steady-state exposure to olaparib• To evaluate the effect of anastrozole on exposure to olaparib…
This is an open label proof of principle study, in 14 patients. The objective of the study is to test the efficacy and safety of ARA 290 in patients with active rheumatoid arthritis. To assess the efficacy, disease activity is examined based on…
Primary: Safety and tolerability.Secondary: Clinical and endoscopic remission, symptomatic clinical remission, clinical response, mucosal healing, health related QoL, CRP, faecal calprotectin, pharmacokinetics.
PRIMARY OBJECTIVES- To investigate the PK profile of GLPG2451 administered as two doses of a capsule formulation in healthy subjects.- To assess the safety and tolerability of GLPG2451 administered as two doses of a capsule formulation in healthy…
- To assess the relative bioavailability of GLPG2737 administered as a single capsule compared to a single oral suspension in the fed state.- To assess the safety and tolerability in healthy subjects of GLPG2737 administered as a capsule and as an…
- To evaluate the pharmacokinetic (PK) profile of the combination of GLPG3067, GLPG2222, and GLPG2737 following repeated morning versus evening doses given to healthy female subjects - To evaluate the safety and tolerability of the combination of…
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…
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…
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…
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…
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To evaluate the long-term safety and efficacy of BMN 110 administration at 2.0 mg/kg/qw and 2.0 mg/kg/qow in patients with MPS IVA.
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
The objective of the study is to determine whether 11C-metomidate PET can differentiate between BAH and APA./PAH
The primary objective will be to assess the safety and tolerability of this combination and to determine whether the MTD ofEMD 521873 is reached up to a dose of 0.45 mg/kg. Secondary objectives will be the evaluation of the PK, immunogenicity,…