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A Nutritional intervention study to evaluate the effect Of Bovine Lactoferrin on innate immunity in Elderly people

Aim of the current study is to evaluate the effect of lactoferrin on the innate immune response in elderly in a pilot study. Furthermore, support of this effect by GOS and Vitamin D will be studied.

Randomized, multicenter, double-blind, placebo-controlled, parallel group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

The primary objective of the study is to determine the efficacy of 2 different doses of IgPro20 (0.2 g/kg bw and/or 0.4 g/kg bw) in the maintenance treatment of CIDP in comparison to placeboSecondary objectives:* To investigate the efficacy of…

The effects of BCG-vaccination on the immune response induced by influenza-vaccination in healthy volunteers. A pilot proof-of-principle study.

Primary objective: The primary objective of the study is to determine the effects of BCG-vaccination on the immune response induced by subsequent influenza vaccination in healthy volunteers. This will be determined by measuring the Th1/Th2 response…

Phase I, double-blind, randomized, placebo-controlled trial to examine the safety, tolerability and plasma pharmacokinetics of increasing single oral doses of TMC558445 with and without food, and increasing repeated oral doses in combination with a single dose of TMC310911.

Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…

Phase I, double-blind, randomized, placebo-controlled trial in healthy volunteers to examine the safety, tolerability and plasma pharmacokinetics of TMC589337 and TMC589354 after increasing single oral doses and in an open-label part after different repeated oral doses in combination with a single oral dose of TMC310911.

To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS

Primary :To investigate the safety and tolerability of ascending single oral doses of JTK-656 administered to healthy male subjectsSecondary:To determine the pharmacokinetics (PK) of ascending single oral doses of JTK-656 administered to healthy…

A Phase III, randomized, double-blind study of TMC278 75 mg q.d. versus efavirenz 600 mg q.d. in combination with a fixed background regimen consisting of tenofovir disoproxil fumarate and emtricitabine in antiretroviral-naïve HIV-1 infected subjects.

The primary objective of the trial is to demonstrate non-inferiority of treatment with TMC278 when administered as 75 mg q.d. compared to the control group (EFV) in regard to the proportion of virologic responders (plasma viral load < 50 HIV-…

A Phase 3b, Randomized, Double-Blind Switch Study to Evaluate the Safety and Efficacy of Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) Fixed Dose Combination (FDC) in HIV-1 Positive Subjects who are Virologically Suppressed on Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate (FTC/RPV/TDF)

Main objective:To evaluate the non-inferiority of switching to the FTC/RPV/TAF FDC as compared to continuing FTC/RPV/TDF FDC in virologically suppressed HIV-1 infected subjects as determined by maintaining HIV-1 RNA < 50 copies/mL at Week 48…

An open-label, non-randomized, within-patient dose-finding study followed by a randomized, subject, investigator and sponsor-blinded placebo controlled study to assess the efficacy and safety of CDZ173 in patients with APDS/PASLI (Activated phosphoinositide 3-kinase delta syndrome/
p110*-activating mutation causing senescent T cells, lymphadenopathy and immunodeficiency)

This trial is, along with establishment of the safety, tolerability and pharmacokinetics and -dynamics of CDZ173 in the target population, designed to select the optimal dose to normalize the function of the PI3K protein in patients with APDS/PASLI…

A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy.

To evaluate the safety and immunogenicity of iHIVARNA-01 as a new therapeutic vaccine in HIV infected patients.