26 results
This proof-of-mechanism (POM) study in subjects with early AD, being subjects asymptomatic at risk for AD and subjects with pAD, is performed to confirm a drug interaction with the intended enzyme (BACE) at the intended target location (brain) by…
The primary objective of the study is:To evaluate efficacy of two doses of ESN364 versus placebo when administered for 12 weeks to decrease total testosterone (TT) levelsThe Secondary objectives are:To evaluate effect of two doses of ESN364 versus…
The objectives of the trial are:1. To investigate the tolerability and safety of SP-35454 following single and multiple dose oral administration.2. To investigate the single and multiple dose pharmacokinetics of SP-35454 and its metabolite SP-…
This safety study in subjects in the early (predementia) AD spectrum is performed to investigate primarily the safety and tolerability of JNJ-54861911 during 6 months of treatment.
Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…
Primary Objectives•To assess and compare the efficacy of five doses of HM11260C (once weekly subcutaneous injections) over the 12 weeks from baseline in comparison with placebo (once weekly subcutaneous injections) on glycaemic control, as assessed…
The main goal of the study is to investigate if small amounts of dopamine could influence engagement during reading, comprehension of the story and vocabulary learning and to investigate if the effect of dopamine is different for carriers of the…
Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…
Primary: The primary objective of this study is to assess relative to placebo, the efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…
The primary objective of the study is to evaluate the efficacy of intralesional administration of eASCs (CX-401) when added to standard surgical care and drainage for the treatment of complex perianal fistulas in patients with Crohn*s disease (CD).
The objectives of this exploratory trial are:1. To measure the pharmacodynamic (PD) effect on parameters derived from 24-hpH/impedance (MII) monitoring,2. To explore the effect on symptoms,3. To evaluate the safety and tolerabilityof treatment with…
The aim of this study is to assess the effect of AZD1981 on histology (lung tissue biopsy) and inflammatory cells (broncho alveolar lavage [BAL] and induced sputum), symptoms, lung function, exercise tolerance and on inflammatory mediators in sputum…
To determine the safety and tolerability of P1201-07 administered as single ascending oral doses in overweight or obese but otherwise healthy subjects.
To investigate the efficacy and safety of BIBF 1120 as compared to placebo in patients with stage IIIB/IV or recurrent non small cell lung cancer treated with standard therapy of pemetrexed after failure of first line chemotherapy.
Primary ObjectivesPart 1:To characterize the safety and tolerability of single ascending doses of PTC518 in healthy subjects.Part 2:To characterize the safety and tolerability of PTC518 administered for 14 or up to 21 days in healthy subjects.Part 3…
The primary objective of this study is to assess the efficacy, measured by OS, of capivasertib + docetaxel versus placebo + docetaxel, with both groups receiving continuous ADT. The primary endpoint is OS in patients who have mCRPC and have received…
To investigate the safety and tolerability of GSK2556286 after single ascending and repeat oral doses in healthy adult participants.To determine the pharmacokinetics of single and repeat oral doses of GSK2556286 in healthy participants.To assess the…
PrimaryTo evaluate the safety and tolerability of single and multiple doses of TBAJ-587 in healthy participants.SecondaryTo determine the pharmacokinetics (PK) of single and multiple doses of TBAJ-587 and metabolites M2, M3 and M12. To compare the…
The primary objectives for this study are:To evaluate the preventive effect of GYM329 on disuse muscle atrophy in healthy male volunteers through changes in muscle strength following a single subcutaneous administration prior to unilateral thigh and…
Primary objectives: • To determine the safety and tolerability of a single administration and single-day IDR of intravenous GH002.• To determine the pharmacokinetics (PK) of 5-MeO-DMT in healthy volunteers following a single administration and…