38 results
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…
This will be the first study with JNJ-63733657 in humans to investigate the safety, tolerability and pharmacokinetics of JNJ-63733657 and to explore potential pharmacodynamic (PD) effects in healthy subjects following single dose administration and…
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 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…
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…
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…
To assess the safety and tolerability profile of escalating dose levels of ESB1609 when administered as once daily (qd) oral doses for up to 25 days in healthy volunteers.
Primary* Part 1 (Dose Escalation): To characterize the safety of JNJ-64407564 and recommend thePhase 2 dose(s) and schedule* Part 2 (Dose Expansion): To further characterize the safety of JNJ-64407564 at the recommended Phase 2 dose(s) (RP2Ds)* Part…
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…
Part IPrimary objectiveTo investigate the pharmacokinetics of the main metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of 3 different controlled release tablet formulations (FP187: V1, V2B, and V3B) and…
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-…
Primary objective* To investigate the plasma pharmacokinetics of the first metabolite of dimethyl fumarate (DMF) - monomethyl fumarate (MMF) - following administration of the delayed- and slow-release FP187-GC tablet formulation after single dose…
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…
-To identify a safe dose of MK-8408 in HCV infected patients that mediates a 3Log10 reduction-To evaluate safety and tolerability of MK-8408 administered for 5 consecutive days-To evaluate the plasma pharmacokinetic profile of multiple oral doses of…
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: 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…
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…