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A phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple-dose subcutaneous and intravenous administration of OMS721 in healthy subjects

The purpose of the study is to investigate to what extent OMS721 is tolerated. This study will also investigate how quickly and to what extent OMS721 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, this study…

A first-in-human, randomized, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to investigate the safety, tolerablility, pharmacokinetics (including food and gender effect), and pharmacodynamics of LNP1955 in healthy subjects.

The purpose of the study is to investigate to what extent LNP1955 is tolerated and safe.It will also be investigated how quickly and to what extent LNP1955 is absorbed and eliminated from the body (this is called pharmacokinetics). Further, the…

Brimonidine Tartrate for the Treatment of Injection Related Erythema Associated with Sub-cutaneous Administration of Peginterferon beta-1a

Primary ObjectivesTo evaluate the IRE intensity/color mitigation effect of a single administration of Brimonidine tartrate in comparison with a vehicle gel (placebo).Secondary ObjectiveTo evaluate the IRE intensity/color mitigation effect of a…

A Multicenter, Randomized, Double-Blind, Study Comparing the Efficacy and Safety of Continuing Versus Withdrawing Adalimumab Therapy in Maintaining Remission in Subjects with Non Radiographic Axial Spondyloarthritis

The objective of this study is to evaluate the efficacy and safety of continuing versus withdrawing therapy with adalimumab 40 mg given every other week (eow) SC in maintaining remission in subjects with nr-axSpA.

A single-center, randomized, double-blind, placebo-controlled, single ascending dose study to investigate the pharmacokinetics, pharmacodynamic effects, safety and tolerability of single doses of RO5459072 in healthy volunteers.

The purpose of the study is to investigate to what extent RO5459072 is safe and well tolerated. It will also be investigated how quickly and to what extent RO5459072 is absorbed, distributed to and removed from the body (this is called…

A two part, phase 1, randomised, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of GBR 830 in adult healthy volunteers (Part 1) and a randomised, placebo-controlled, pharmacodynamic study to evaluate the effect of single dose of GBR 830 on vaccination response in adult, healthy volunteers (Part 2)

The purpose of this study is to investigate to what extent GBR 830 is tolerated. It will also be investigated how quickly and to what extent GBR 830 is absorbed and eliminated from the body (this is called pharmacokinetics) and to what extent the…

Systemic antihistamines in the treatment of attention-deficit/hyperactivity disorder (ADHD): a pilot study.

Primary objectiveTo assess whether the use of alimemazine improves symptoms of allergic diseases and ADHD, as scored by the parents using standardized questionnaires (Sample Snap IV rating scales)

Effects of Single Dose of Bilastine 20mg on Flying Ability in Healthy Volunteers Under Conditions of Simulated Cabin Pressure

Objective: The response over time on daytime alertness and performance will be assessed following a single oral dose of bilastine 20 mg in healthy volunteers performing flying ability tests in a hypobaric chamber with an ambient pressure of 75.2 kPa…

A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to
Assess the Efficacy and Safety of HDM-SPIRE in Subjects with a History of House
Dust Mite-Induced Rhinoconjunctivitis

To evaluate the efficacy of HDM-SPIRE in the reduction of symptoms and the use of allergy rescue medication associated with HDM allergy in subjects with clinically relevant symptoms.

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…

Evaluation of Pharmacokinetics, Relative Bioavailability, and Tolerability of Three Different Formulations of PA101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Chronic Cough due to Idiopathic Pulmonary Fibrosis

The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…

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…

A SINGLE-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ASCENDING DOSE STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMIC EFFECTS, SAFETY AND TOLERABILITY OF REPEATED DOSING OF RO5459072 IN HEALTHY SUBJECTS

The purpose of the study is to investigate to what extent RO5459072 is safe and well tolerated.It will also be investigated how quickly and to what extent RO5459072 is absorbed, distributed to and removed from the body (this is called…

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 I, Single-Centre, Randomized, Double-Blind, Placebo Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ARA 290 Administered Intravenously to Healthy Subjects, and extension in renal patients

The present study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARA 290 administered intravenously to healthy subjects, and of intravenously and subcutaneously administered ARA 290 to renally impaired subjects.

A Phase III, 3-Arm, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study to Investigate the Impact of Diamyd® on the Progression of Diabetes in Patients Newly Diagnosed with Type 1 Diabetes Mellitus.

The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…

A Phase 2/3, Randomized, Double-Blind, Multicenter, Multinational, 4-Arm,
Controlled, Dose-Ranging Study to Evaluate Efficacy and Safety of Teplizumab
(MGA031), a Humanized, FcR Non-Binding, Anti-CD3 Monoclonal Antibody, in
Children and Adults with Recent-Onset Type 1 Diabetes Mellitus

Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…

A randomized, double-blind, placebo-controlled, phase 2 study to evaluate the safety and efficacy of CCX354-C in subjects with rheumatoid arthritis partially responsive to methotrexate therapy.

The primary objective of the study is to evaluate the safety and tolerability of CCX354-C in subjects with rheumatoid arthritis (RA) who had an inadequate response to methotrexate treatment.The secondary objectives of the study are to evaluate the…

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…

Beyond conventional treatment of Atopic eczema in infants: Management By specific prObiOtic strains. A double blind placebo-controlled trial.

To investigate the therapeutic effect of a selected probiotic mixture on the severity of AD in infants aged 0-15 months. The probiotic mixture has been studied in vitro and has proven IL-10 stimulating effects. Therefore it is thought to decrease AD…