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A First-in-Human, randomized, double-blind, placebo-controlled ascending dose study to assess safety, tolerability, pharmacokinetics and pharmacodynamics of STR-324 in healthy subjects.

To investigate the safety, tolerability and efficacy of STR-324 infusions in healthy subjects.Primary objective (Parts 1 and 2)* To assess and characterise the safety and the tolerability of STR-324, over a 4-hour (Part 1) and a 48-h infusion (Part…

Effect of High-volume Online hemodiafiLtration on intra-diaLytic hemodynAmic (iN)sTability and cardiac function in chronic hemodialysis patients (the HOLLANT study)

This study aims at improving the knowledge concerning HV-HDF and thus helps to tailor the optimal ERRT for each individual patient.The following hypotheses will be tested:1. Intra-dialytic hemodynamic stability is better preserved during HV-HDF as…

Randomized, Blinded, 2 stage, 2-way Crossover Bioequivalence Study of Mentholatum 10% w/w Ibuprofen Gel and Ibuleve 10% w/w Ibuprofen Gel Administered as a Single Application of 125 mg in Healthy Subjects

This study will compare the study compound Mentholatum 10% w/w Ibuprofen Gel to a similar product, which is already on the market in UK called Ibuleve Maximum Strength Gel. The purpose of the study is to compare these two gels in how quickly and to…

Single-center, randomized, double-blind, single-dose, 3-way crossover study to compare the effects of daridorexant and placebo on postural stability, the auditory awakening threshold, and cognitive function in the middle-of-the-night following evening administration to healthy adult and elderly subjects

To evaluate the pharmacodynamic (PD) effects of daridorexant 25mg, 50mg, and placebo in the middle-of-the-night.

A trial to assess the injection site pain experience of excipient solutions relevant for subcutaneous injection

The primary objective is to assess, in healthy subjects with a body mass index (BMI) greater than or equal to 25.0 kg/m2, the injection site pain experience of 9 excipient solutions (Trial Products 4 to 12), intended to be used in future…

A bridging trial to compare the pharmacokinetics of Glepaglutide (ZP1848) after a single subcutaneous administration by vial/syringe and by autoinjector in healthy subjects: a phase 1, randomized, open-label, three-way, reference-replicated crossover trial

- To compare the pharmacokinetics (PK) of glepaglutide after a single subcutaneous (SC) administration by vial/syringe and by autoinjector.- To evaluate the safety and tolerability of glepaglutide following SC dosing in healthy subjects.

DIStal versus COnventional RADIAL access for coronary angiography and
intervention: a randomized multicenter trial

The objective of this study is to demonstrate the superiority of Distal Transradial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO) using the 6Fr Glidesheath Slender (GSS).

A Multicenter, Randomized, Placebo-Controlled, Double-Blind Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAR443060 in Subjects with Amyotrophic Lateral Sclerosis (ALS)

Double-blinded part:The primary objectives of the study are as follows:• To investigate the safety and tolerability of 28 days of oral doses of SAR443060 in subjects with ALS.The secondary objectives of the study are as follows: • To characterize…

Randomized, double-blind, placebo-controlled crossover study to validate finger tapping tasks for the quantification of levodopa/carbidopa effects in Parkinson*s Disease patients.

Primary ObjectivesAssess whether the finger tapping task endpoints:• Differentiate between ON and OFF states in PD patients• Correlate with the MDS-UPDRS part III total score• Differentiate between placebo and levodopa/carbidopa treatmentSecondary…

Randomized, double-blind, placebo-controlled single ascending dose study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics and food-effects of YTX-7739, a novel oral inhibitor of Stearoyl-CoA-desaturases, in healthy volunteers

* Part A: To investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of YTX-7739 in healthy subjects. * Part B: To study the effect of food on pharmacokinetics of YTX-7739 in a selection of subjects who…

A multicenter, randomized, double-blind, placebo-controlled, crossover trial to evaluate the effects of evolocumab added to standard lipid-lowering therapy on fasting and post fat load lipids in patients with Familial Dysbetalipoproteinemia.

To evaluate the effect of 12 weeks subcutaneous evolocumab (140 mg pre-filled pen every 2 weeks) compared to placebo on post fat load non-HDL-C levels in 30 subjects with FD, in a multicenter, randomized, placebo-controlled, double-blind, crossover…

An Open-label, Randomized, Crossover, Single Ascending Dose Pharmacokinetic Study of Continuous Subcutaneous Infusion of Lenalidomide Compared with Revlimid® Oral Capsules in Healthy Adult Male Subjects

The purpose of this study is to investigate how quickly and to what extend lenalidomide is absorbed and eliminated from the body (this is called pharmacokinetics). In this study the pharmacokinetics will be compared when lenalidomide is administered…

A phase I, open-label, randomized, three-way cross-over study comparing bioavailability of two formulations and assessing the food effect on tablet formulation after PXL770 single oral dose in healthy subjects

The purpose of this study is compare a tablet formulation of PXL770 to the capsule formulation of PXL770. It will be investigated how quickly and to what extent PXL770 in each formulation is absorbed and eliminated from the body. To limit the…

A phase 1, double-blind placebo-controlled single and multiple ascending dose study of the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of IFM-2427 in healthy subjects

The purpose of this study is to investigate how safe the new compound IFM-2427 is and how well it is tolerated when it is administered to healthy volunteers. IFM-2427 has not been administered to humans before; it will be administered to healthy…

An open-label, single-sequence crossover drug-drug interaction study to evaluate the effect of multiple oral doses of itraconazole on the pharmacokinetics of PHA-022121 in healthy subjects

The purpose of this study is to investigate the effect of multiple doses of itraconazole on how quickly and to what extent the new compound PHA-022121 is absorbed into the body and eliminated from the body (this is called pharmacokinetics). It will…

Assessment of Neublastin-Induced Skin and Sensory Alterations and Headache in Healthy Subjects and Migraine Patients

Primary Objectives1. To assess pruritus and rash after administration of Neublastin or placebo in healthy subjects and migraine patients (Parts A and B)2. To assess headache and other migraine-associated symptoms after administration of Neublastin…

rTMS and cognitive control training in the context of depression

In this study, we want to combine rTMS and CCT to assess whether the combination of these two treatment would have synergistic effects and strengthen each other. We specifically want to assess the effect on mood and cognitive control, in a group of…

An open-label, randomized, single center, crossover study in healthy participants to assess lipoprotein lipase activity and levels, and triglyceride levels after heparin exposure, in both fasted and postprandial state

In this study we will investigate biomarkers in blood after exposure to heparin in the fasted state or after a high-fat meal. Biomarkers are proteins present in the blood. The biomarkers investigated in this study are proteins that are involved in…

A Two-Part, Open-Label, Single-Dose Relative Bioavailability and Food Effect Study of THB001 in Healthy Adults

Part 1:Primary objective:• To estimate the relative bioavailability of two THB001 formulations in healthy adults.Secondary objectives:• To determine the single-dose pharmacokinetics (PK) of THB001•HCl salt and THB001 free base formulations in…

A Randomised Feasibility n-of-1 Trial of Weekly-Interval Red Cell Transfusion in myelodysplastic syndromes; Red blood cell transfusion schedule in myelodysplastic syndromes (REDDS): study 2

This protocol describes a two-part study to assess red blood cell (RBC) transfusion schedules in patients with transfusion-dependent myelodysplastic syndromes (MDS).The first part of the study is a pilot n-of-1 study to assess the feasibility of a…