94 results
Stage 1* To assess the safety and tolerability of single-ascending-dose levels of IW-6463 when administered to healthy subjectsStage 2* To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 when administered to healthy…
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…
Part A: healthy volunteers Primary objective- To determine safety and tolerability of a single dose of VB5-845D-800CW in healthy volunteers.Secondary objective- To determine the pharmacokinetics of VB5-845D-800CW by measuring fluorescence in blood…
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.
Objectives for Part A1 Monotherapy Dose EscalationPrimary Objective:* To assess safety, and tolerability at increasing dose levels of PF 04518600 in patients with selected advanced or metastatic solid tumors in order to establish the MTD.Secondary…
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…
To evaluate the incidence of grade * 3 neutropenia (measured at Day 7 and Day 14) and/or neutropenic complications (febrile neutropenia, neutropenic infection) with two schedules of cabazitaxel (bi-weekly versus tri-weekly) plus prednisone in…
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…
The primary study objective is to determine the safety profile and tolerability of S64315 in patients with AML and MDS and to determine the recommended phase 2 dose. Secondly, the PK profile of S64315 and potential metabolites will be determined in…
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…
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.…
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.
The primary objectives of this study are to:* Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using an intermittent…
PHASE IIPrimary ObjectiveThe primary objective of the Phase II portion of the study is to estimate the efficacy as measured by radiographic progression-free survival of IPATASERTIB (GDC-0068) (dosed at either 400 mg or 200 mg daily) + abiraterone…
Efficacy and safety trial with S 44819 after recent ischemic cerebral Event
The purpose of the study is to investigate to what extent FE 201836 is tolerated. It will also be investigated how quickly and to what extent FE 201836 is absorbed and eliminated from the body (this is called pharmacokinetics). Also the effect on…
The objective of the present phase 2 trial is to evaluate the safety, pharmacodynamics (effect on HPA axis and calcium metabolism) and pharmacokinetics of LEO 90100 in adolescent subjects with plaque psoriasis. Subjects will be treated once daily…
To assess the potential of the PET-tracer [11C]SMW139 to investigate the role of P2X7R, a cell surface receptor upregulated in activated microglia, in neuroinflammation in PD. The aim is to find the optimal tracer kinetic model which can be used to…
To evaluate the effect of AMG 334 compared to placebo on the change from baseline in mean monthly migraine days, in subjects with episodic migraine.hypothesis: In subjects with episodic migraine, AMG 334 has a greater reduction from baseline in mean…