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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…

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…

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 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…

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…

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…

oral PHA-022121 for the acute treatment and prophylaxis Of angioedema attacks in Patients with Acquired C1-Inhibitor Deficiency

Primary objectives: to evaluate the efficacy of three different single doses of PHA-022121 versus placebo in achieving angioedema symptom relief during acute attacks and the efficacy of prophylactic treatment with PHA-022121 versus placebo in…