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Healthy Volunteers clinical trials

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NCT ID: NCT01715623 Completed - Healthy Volunteers Clinical Trials

Polymorphism of the IgH Locus Regulatory Region as a Prognostic Factor During Immune Pathologies.

PRIERR
Start date: October 2012
Phase:
Study type: Observational

The investigators previously showed that both antibody class switching (from IgM to IgG, IgA or IgE) and antibody secretion are controlled by a polymorphic "3' regulatory region" (3'RR) of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its genetic polymorphism might influence not only the occurrence of immunopathologic processes involving class-switched antibody deregulated production but also the severity of such diseases or the time course of their progression. We wish to focus on two conditions involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities, and on the other hand a disease involving pathogenic IgA and for which the prognosis is currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura (HSP). Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to focus on homogeneous groups of patients and we thus wish to concentrate on two groups of patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms and severe food allergies related to peanut allergens sensitization. These groups will be built by considering multiple clinical criteria (clinical history, severity of the manifestations, positive skin tests, and positive oral provocation tests for peanut allergens…) and biological criteria authenticating the mechanisms of the disease (high specific serum IgE, demonstration of specific basophil activation by the allergen…). In parallel to the study in patients, we will include a large cohort of healthy controls (400 individuals), in order to be able to decipher whether correlations can be seen between: - IgH 3'RR genotypes - The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory) and IgE (highly pro-inflammatory and responsible for hypersensitivities) - IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as correlated with varying levels of IgG and IgE production in normal individuals).

NCT ID: NCT01714960 Completed - Clinical trials for Healthy Volunteers and Glaucoma Patients

Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients

Start date: October 2012
Phase: Phase 1
Study type: Interventional

- To assess the safety and tolerability of repeat dose topical administration of MRZ-99030 Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma subjects (stage 2). - To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030 Ophthalmic Solution.

NCT ID: NCT01714154 Completed - Healthy Volunteer Clinical Trials

A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls

Start date: November 2012
Phase: Phase 1
Study type: Interventional

This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.

NCT ID: NCT01711801 Completed - Healthy Volunteer Clinical Trials

A Study of Safety, Pharmacokinetics (Including Food Effect) And Pharmacodynamics of RO5545965 in Healthy Volunteers

Start date: October 2012
Phase: Phase 1
Study type: Interventional

This randomized, Investigator/Subject-blind, adaptive single-ascending-dose, placebo-controlled, parallel study will evaluate the safety, tolerability, pharmacokinetics (including the effect of food), and pharmacodynamics of RO5545965 following oral administration in healthy male volunteers. In Part 1, subjects will be randomized in cohorts to receive single ascending doses of RO5545965 or placebo. In Part 2, subjects will receive 2 doses of RO5545965, in the fed or fasted state, in randomized sequence with a washout period of approximately 2 weeks between treatment periods.

NCT ID: NCT01711775 Completed - Healthy Volunteer Clinical Trials

A Pharmacokinetic Study of Aleglitazar in Healthy Chinese Volunteers

Start date: November 2012
Phase: Phase 1
Study type: Interventional

This single-center, non-randomized, open-label study will assess the pharmacokinetics of aleglitazar after administration of single and multiple oral doses in healthy Chinese volunteers. Subjects will receive a single oral dose of aleglitazar on Day 1 and repeated oral doses once daily from Day 5 to Day 14. Anticipated time on study, including screening and a 2-week follow-up, is up to 8 weeks.

NCT ID: NCT01711762 Completed - Healthy Volunteer Clinical Trials

A Pharmacokinetics Study of Radioactive-Labeled GDC-0973 in Healthy Male Volunteers

Start date: September 2012
Phase: Phase 1
Study type: Interventional

This open-label, non-randomized study will assess the absorption, metabolism, and excretion of radioactive-labeled [14C]-GDC-0973 in healthy male volunteers. Volunteers will receive a single dose of [14C]-GDC-0973.

NCT ID: NCT01710670 Completed - Healthy Volunteers Clinical Trials

A Study to Investigate the Drug-Drug Interactions of Brivaracetam and Ethanol in Healthy Male Subjects

Start date: September 2012
Phase: Phase 1
Study type: Interventional

To evaluate if Brivaracetam (BRV) influences the psychomotor and cognitive impairing effects of Ethanol

NCT ID: NCT01708616 Completed - Healthy Volunteer Clinical Trials

A Study of the Combination of Multiple Doses of RO5285119 With a Single Dose of Risperidone in Healthy Volunteers

Start date: November 2012
Phase: Phase 1
Study type: Interventional

This single-center, randomized, double-blind, two-period crossover study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of the combination of multiple doses of RO5285119 with a single dose of risperidone in healthy volunteers. Subjects will be randomized to one of 4 treatment sequences of two periods to receive multiple doses of RO5285119 plus a single dose of risperidone or risperidone placebo or multiple doses of RO5285119 placebo plus a single dose of risperidone or risperidone placebo, with a washout period of approximately 3 weeks between treatment periods. Anticipated time on study is up to 12 weeks (from screening through study completion).

NCT ID: NCT01704222 Completed - Healthy Volunteers Clinical Trials

Epidemiology of Human Cytomegalovirus Excretion in the Saliva of Children Attending Nursery in France

CrèchMV
Start date: September 2009
Phase: N/A
Study type: Observational

Direct DNA amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in France Sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

NCT ID: NCT01704040 Completed - Clinical trials for Healthy Volunteers and Asthma

A Study of CNTO 3157 in Healthy Normal and Asthmatic Participants Inoculated With Human Rhinovirus Type 16

Start date: October 2012
Phase: Phase 1
Study type: Interventional

The main purposes of this study are to evaluate the safety (Parts 1 and 2) and efficacy (Part 2) of pretreatment with CNTO 3157 in healthy adult and asthmatic adult participants before and after intranasal (into the nose) inoculation with human rhinovirus type 16 (HRV-16).