108 results
To assess the safety and tolerability of MHS552 of single i.v./s.c. doses. Cohort 1-5 will be i.v. and cohort 6-8 will be s.c. In addition, in each of the 5 first cohorts, a sentinel group is included.
Primary objectivePart 1: To investigate whether sTHC is released from a new chewing gum formulation.Part 2: To investigate the bioavailability of THC from chewing gum using dronabinol capsules as comparator in healthy male and female subjects.…
To assess the safety and efficacy of DBV712 in initiating desensitisation of peanut in children aged 1 to 3 years with peanut allergy, after 12 months of treatment with Epicutaneous Immunotherapy EPIT).
Part A: healthy volunteers (n=up to 15)Primary/safety objective: - To assess the safety, tolerability and pharmacokinetics of a single IV dosage of OTL78 Secondary objective: - To assess the pharmacodynamics of OTL78 by measuring the temporal…
The main goal of this study is to evaluate efficacy of a single administration of ATH3G10 in patients presenting with an acute STEMI undergoing PCI.The primary objective is to investigate effects on left ventricular remodelling as measured by the…
Primary objective- To evaluate the effects of ACT-541468 on objective simulated driving performance, i.e., the standard deviation of the lateral position (SDLP), after single- and multiple dose administrations (i.e., on Day 1 and Day 4) in the…
Primary Objective* To explore the pharmacodynamics of ICVT comprised of digoxin and furosemide (dual agent), digoxin (single agent), furosemide (single agent) in patients with AK. * To evaluate clinical efficacy of ICVT comprised of digoxin and…
Primary objective:To demonstrate that tralokinumab in combination with TCS is superior to placebo in combination with TCS in treating moderate-to-severe AD.Secondary objectives:To evaluate the efficacy of tralokinumab in combination with TCS on…
Primary ObjectivesThe main purpose of this study is to compare how long subjects with oesophageal cancer live overall (called overall survival, OS) or live without disease progression (called progression free survival, PFS) after receiving BMS-…
The aim of this study is to evaluate the dosimetry and toxicity of Lutetium-177-PSMA-617, in patients with low volume, hormone sensitive metastatic prostate cancer.
To explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of LOU064 over a treatment period of 4 weeks in a cohort of subjects with atopic dermatitis.
CD is a chronic, relapsing-remitting, inflammatory disease of the GI tract. Some patients may have persistent clinically active disease. The current treatment options for patients with moderate to severe CD, refractory to standard therapies that…
Primary: To investigate if CVL-865 decreases subjective anxiety symptoms elicited by a 35% CO2 inhalation challenge.Secondary: To investigate if CVL-865 decreases subjective fear symptoms elicited by a 35% CO2 inhalation challenge. To investigate if…
Primary Objectives:The primary objective of this study is to characterize the effect of repeated oral administration of TAK-788 160 mgQD on the single oral- and IV-dose PK of midazolam.Secondary Objectives:The secondary objective of this study is to…
Primary objective: To evaluate the safety and tolerability of GSK1795091 when administered in combination with either GSK3174998, GSK3359609, orpembrolizumab.Secondary objectives: * To evaluate the antitumor activity of GSK1795091 when administered…
Part A: Determine safety and tolerability of FTX-1821 in healthy subjects. Part B and C: Determine safety and tolerability of FTX-1821 in FSHD patients.
Primary Objective: To assess the safety of rVA576 in adult subjects with mild to moderate bullous pemphigoid (BP).Secondary Objectives: To assess the efficacy of rVA576 and its effect on the quality of life in adult subjects with mild to moderate…
Primary Objectives:• To assess the efficacy (progression free survival [PFS]) of DCC 2618 by independent radiologic review in patients with advanced gastrointestinal stromal tumors (GIST) who have received prior therapiesKey Secondary Objectives:•…
Primary- Part A: Evaluation of pharmacodynamic (PD) interaction between steady-state treatment with padsevonil (PSL) and ethanol- Part B: Evaluation of pharmacokinetic (PK) interaction between steady-state treatment with padsevonil (PSL) and…
Part 1 Single Ascending Dose (SAD)- To evaluate the safety and tolerability of a single oral dose of prodrug, ABX-002, in healthy adult subjectsPart 2 Multiple Ascending Dose (MAD)-To evaluate the safety and tolerability of once daily oral doses of…