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A randomized, double-blind, two-way crossover study to compare the pharmacokinetics, pharmacodynamics and safety of a single subcutaneous administration of LA-EP2006 and a single subcutaneous administration of Neulasta® (EU-authorized) in healthy subjects

The purpose of the study is to compare LA-EP2006 and Neulasta® with respect to how quickly and to what extent the compounds are absorbed and eliminated from the body after injection under the skin of the abdomen (this is called pharmacokinetics). It…

Effects of BCG vaccination on immunological characteristics of hematopoetic stem cells: an explorative study

To examine the effect of BCG vaccination on the composition and function of the bone marrow.

Investigating normal variability in brain volumes and cognition in a healthy population.

The objective of the current study is to obtain normative data of healthy individuals on brain measures, cognition and blood markers. In addition, we acquire information on childhood trauma, metabolic and immunological parameters in a cohort of…

A Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and
Safety of CNTO 328 (Anti-IL-6 Monoclonal Antibody) Plus Best Supportive Care
Compared With Best Supportive Care in Subjects With Multicentric Castleman*s
Disease

Primary Objective:The primary objective of this study is to demonstrate that CNTO 328 in combination with BSC is superiorto BSC in terms of objective response (complete response [CR] + partial response [PR]) among subjectswith multicentric Castleman…

SINGLE-CENTER, OPEN-LABEL, RANDOMIZED, TWO-PARTS, TWO-WAY CROSSOVER STUDY TO INVESTIGATE THE EFFECTS ON HEART RATE, BLOOD PRESSURE, AND PHARMACOKINETIC INTERACTIONS OF ACT-128800 COMBINED WITH A CALCIUM-CHANNEL BLOCKER OR A BETA-BLOCKER IN HEALTHY SUBJECTS

Primary:to investigate the effects on heart rate (HR) and rhythm of concomitant administration of the study drug with a calcium-channel blocker (CCB) or a beta-blocker (BB)Secondary:- to investigate the effects on blood pressure (BP) of concomitant…

The effects of immunostimulation with GM-CSF or IFN-γ on immunoparalysis following
human endotoxemia.
A parallel randomised double-blind placebo-controlled study

Primary objective: The primary objective of the study is to determine the effects of GM-CSF/IFN-γ on the in vivo immunoparalysis induced by human endotoxemia. This will be determined by measuring plasma levels of various pro and anti-inflammatory…

SCONE Study
Studies on Complement regulation in atypical hemolytic uremic syndrome following hemodialysis, plasmapheresis and treatment with Eculizumab

Objective: To analyze in more detail the complement activation and regulation and especially the functional CFH activity following three types of interventions in patients known with HUS and correlate these to clinical findings. The three…

Effects of orally administered Beta-Glucan on leukocyte function in humans, a pilot study

The primary objective of the study is to evaluate the systemic effects of orally administered Beta-glucan on innate immune responses of leukocytes. The effects of Beta-glucan will be determined by measuring the ex-vivo responsiveness of leukocytes…

Single-center, double-blind, randomized, placebo-controlled, single-ascending dose
and food interaction study to investigate the tolerability, safety, pharmacokinetics,
and pharmacodynamics of ACT-389949 in healthy male subjects

• to evaluate the safety and tolerability of ascending single oral doses of the test compound ACT-389949 (test medication) in healthy male subjects• to study how the test compound ACT-389949 is absorbed, broken-down and excreted by the body and how…

Biobank Hematological Stem Cell Transplantation

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A PHASE I, RANDOMIZED, DOUBLE BLIND PLACEBO * CONTROLLED, SINGLE AND MULTIPLE DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF OCID 2987 IN HEALTHY MALE SUBJECTS

Primary:-To determine the safety and tolerability of ascending single and multiple oral doses of OCID 2987 in healthy male subjects.Secondary:-To determine the pharmacokinetics (PK) of single and multiple oral dose OCID 2987 in healthy male subjects…

The intradialytic clearance of polyclonal immunoglobulin free light chains by low-flux hemodialysis, high-flux hemodialysis and online hemodiafiltration .

Study the clearance of immunoglobulin free light chains by HDF, lf-HD and high flux hemodialysis (hf-HD) using polysulphone and polyamide dialyzers.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND THE EFFECT OF FOOD AND KETOCONAZOLE ON THE PHARMACOKINETICS OF IPI-145 WHEN ADMINISTERED TO HEALTHY ADULT SUBJECTS

The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…

Immune monitoring to characterize T-cell responses of kidney transplant patients during co-stimulation blockade by belatacept

Here, we postulate that the balance between the effect of belatacept on regulatory T-cell function and the relative insensitivity of memory T-cells for belatacept leads to donor-specific alloreactivity. We plan to study the peripheral CD28-dependent…

Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial

To evaluate the efficacy, safety and feasibility of combined immune modulation with rituximab, ITI and MSCs in terms of eradication of FVIII inhibitory activity in hemophilia A patients.

A new dosing strategy of infliximab versus standard dosing in patients with severe sarcoidosis: optimization of treatment

Objective: To determine whether serum concentration guided dosing of infliximab is not inferior to standard dosing based on bodyweight in patients with severe sarcoidosis in terms of FVC change at 26 weeks.

The effects of different vasopressors on the innate immune response during experimental human endotoxemia, a pilot proof-of-principle study

Our primary objective is to investigate whether noradrenaline exerts immunomodulatory effects in humans in vivo during experimental human endotoxemia. This will be determined by comparing plasma levels of various pro- and anti-inflammatory cytokines…

Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery

To assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.To assess the anti-inflammatory effects of EA-230 in patients with systemic inflammation following cardiac surgery. To assess the effects…

A PHASE 1, THREE-PART, RANDOMIZED, PLACEBO-CONTROLLED, DOSE-ESCALATION STUDY OF THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND FOOD EFFECT OF AQX-1125 IN HEALTHY HUMAN SUBJECTS

Primary:To assess the safety and tolerability of single and multiple oral ascending doses of the study drug in healthy human subjects (Part 1 and Part 2)To assess the effect of food on the absorption and pharmacokinetic (PK) profile of the study…

Effects of Induced Hypothermia on Respiratory parameters and Immunological function

Observational part on respiratory parametersThe primary objective of this study is to study the effect of hypothermia and rewarming on P/F ratio as a measure of oxygenation and on end tidal CO2 as a measure of ventilation during mechanical…