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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…

The effects of acetylsalicylic acid on immunoparalysis following human endotoxemia

Primary objective:­To determine whether endotoxin tolerance can be prevented by acetylsalicylic acid prophylaxis or can be reversed by acetylsalicylic acid treatment, expressed as an augmentation of pro-inflammatory cytokine levels during the second…

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…

The Effect of Rosuvastatin on Immune Activation Markers in Treatment-naïve HIV-Positive Patients; a Randomized Placebo-Controlled Trial

Primary Objective: to investigate the effect of rosuvastatin 20 mg qd on subsequent immune activation markers in treatment-naïve HIV-patients: circulating LPS (LAL assay), TLR mRNA expression in whole blood, circulating IL-6, D-dimer, hsCRP, CD38…

A Phase III, randomised, double blind, placebo controlled, parallel group study, to evaluate the safety and efficacy of subcutaneous implants of afamelanotide (16 mg) in patients suffering from polymorphic light eruption (PLE).

Primary Objective - To determine if afamelanotide can reduce the severity of PLE related pruritis.Secondary Objectives- To determine if afamelanotide can reduce the frequency of PLE episodes;- To determine if afamelanotide can reduce the duration of…

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…

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…

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…

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…

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…

A study proposal to investigate the sequels of mucosal inflammation caused by ETEC infection- the effects of probiotics

The main objective of this study is to investigate the effect of probiotics on the sequels of ETEC administration as intestinal permeability, inflammation and clinical signs as total faecal output, relative faecal dry weight and mucin excretion in…

Effect of colostrum on immune function after intense strenuous exercise in well-trained cyclists.

The primary objective of this study is to evaluate the effect of colostrum supplementation on the immune response after intense strenuous exercise.The secondary objective is to study the effect of intense strenuous exercise - and its possible…

In vivo effects of C1-esterase inhibitor on innate immune response during endotoxemia in human.

The primary objective is to investigate the effects of intravenous administration of C1INH in human volunteers on cytokine release (TNFa) during endotoxemia. The secondary objective is to determine the effect of administration of C1 INH on…

The effects of BCG-vaccination on the innate immune response and immunoparalysis in healthy volunteers. Two proof-of-principle studies.

In the present study, we first want to investigate whether BCG-vaccination enhances the innate immune response in humans in vivo during human endotoxemia. In the second experiment we want to investigate whether BCG-vaccination can reverse the…

Randomized double blind placebo-controlled clinical safety, tolerability and pharmacokinetic/-dynamic study on the effects of escalating single intravenous doses of EA-230 on the innate immune response during experimental human endotoxemia

Part 1: To assess the safety, tolerability and pharmacokinetic-dynamic response, of single escalating doses of EA-230 in healthy subjects.Part 2: To assess the dose-and plasma concentration-response relation of single escalating doses EA-230 on…

A phase III, multicenter, randomized, double-blind placebo-controlled study to assess the efficacy and safety of Tocilizumab in subjects with giant cell arteritis.

Primary Efficacy Objective:• To evaluate the efficacy of tocilizumab (TCZ) compared to placebo, in combination with a26-week prednisone taper regimen, in patients with giant cell arteritis (GCA), as measured by the proportion of patients in…

Effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur or pelvic fracture.

A previous study of from our laboratory showed that administration of the drug C1-INH (100E/kg) significantly reduced the concentration of circulating pro-inflammatory cytokines, such as IL-6, in healthy male volunteers during human experimental…