16 results
The objectives of the study are:To determine the pharmacokinetic and pharmacodynamic interaction of a single ascending dose of Xen2174 with bupivacaine, and in one cohort of Xen2174 alone, when administered intrathecally to healthy volunteers and…
The objectives of the study are:To determine the pharmacokinetic profile of Xen2174 in plasma and CSF when administered intrathecally to healthy volunteersTo determine which modalities of pain are affected by treatment with Xen2174 when administered…
The primary objective of this study is to assess the relation between the short term metabolic changes after start of rhGH therapy and the long term change in height SDS after one and two years of treatment. Secondly, we want to assess the effects…
Primary objective: Assessment of the value of the short-term (2 weeks) response of IGF-I (peak IGF-I SDS) to GH in a dosage of 1.4 mg/m2/day (as part of a dose-escalation IGF-I generation test) in comparison to baseline IGF-I to predict the 1 year…
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height and the first and five year growth response. Secondly, we want to assess the long term…
The primary objective of this study is to assess the effect of individualizing the growth hormone dose versus standard treatment with 1 mg/m2/day on adult height. Secondly, we want to assess the first and five year growth response, the long term…
to evaluate the effects of GH versus withdrawal of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism, circulating lipids, and respiratory function during transition period until the age…
To evaluate the overall safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjectsTo evaluate the effects of Xen2174, following its administration as a single intrathecal bolus, on EEG activity…
To evaluate whether GH substitution in patients with an isolated GHD after TBI could reverse the severity of symptoms which characterize GHD.
Primary: · To determine the efficacy of DARA plus durvalumab (DURVA) in subjects with RRMM who have progressed on DARA while on a DARA-containing regimen as the most recent MM treatment.Secondary:· Determine the safety of DARA plus DURVA in subjects…
To investigate the effects of GH treatment on body composition, psychosocial development, psychomotor development, growth, glucose metabolism, serum lipids, cognition, behaviour, bone mineral density, quality of life and safety parameters in…
Primary Objective- Compare the safety and efficacy of subcutaneous somavaratan and daily rhGH during 12 months of treatment.Secondary Objective-Evaluate and compare changes in pharmacodynamic responses (IGF-I, IGF binding protein-3 (IGFBP-3), growth…
To assess the impact of 7 daily subcutaneous gifts of GH on circulating Klotho levels in human sugjects with CKD stage III and healthy age-matched controls.
To evaluate the effects of GH, after final height is reached, on weight, body composition, psychosocial functioning, carbohydrate metabolism and serum lipids. To find an optimal dose growth hormone for adults with PWS. We aimed to stabilize the body…
The purpose of this study is to characterize the safety and tolerability of talquetamab when administered in different combination regimens and to identify the safe dose(s) of talquetamab combination regimens.
The purpose of this study is to compare the efficacy of teclistamab and talquetamab both in combination with daratumumab and lenalidomide (Tec-DR and Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).