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A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled 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 efficacyof teplizumab when administered according to 3 different teplizumab dosing regimens in subjects with recent-onset T1DM (within 12 weeks of presentation of…

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 Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of Brodalumab Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis: AMAGINE-2

The objective of this clinical research study is to evaluate the safety and effectiveness of brodalumab, compared with ustekinumab and placebo, for the treatment of moderate to severe plaque psoriasis.

Multicenter, Double-Blind, Randomized, 2-Part, Dose Ranging Study to Compare the Safety, and Antiretroviral Activity of MK-1439 Plus TRUVADA® Versus Efavirenz Plus TRUVADA® in Antiretroviral Treatment-Naïve, HIV-1 Infected Patients

MK-1439 is a promising NNRTI to be used in combination with other antiretrovirals (ARTs) for the treatment of HIV infection. It is a potent inhibitor of HIV-1 replication in vitro and is active against both wild type virus and most common NNRTI…

Dose response trial of IV immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy

The primary objective is:1. To investigate whether high frequency low dosage IVIg treatment is more effective than low frequency high dosage as maintenance treatment for CIDP. Secondary objectives are:2. To investigate whether high frequency low…

A randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics and food effect of orally administered LYC-30937 in healthy male subjects

The purpose of the study is to investigate the safety of LYC-30937 and to what extent LYC-30937 is tolerated. It will also investigate how quickly and to what extent LYC-30937 is absorbed and eliminated from the body (this is called pharmacokinetics…

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…

Protocol I1F-MC-RHBS;A 52-Week Multicenter, Randomized, Blinded, Parallel Group Study Comparing the Efficacy and Safety of Ixekizumab to Ustekinumab in Patients with Moderate to Severe Plaque Psoriasis

The primary objectives of this study are to assess whether 80 mg ixekizumab every 2 weeks (Q2W) is:• noninferior to ustekinumab at Week 12 in the treatment of patients with moderate-to-severe plaque psoriasis as measured by proportion of patients…

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 Randomized, controlled, cross-over Study to assess Hypoallergenicity of an extensively hydrolyzed whey protein Infant formula in children with cow's milk allergy using amino-based infant formula as a reference.

The primary study objective is to assess the hypoallergenicity of an extensively hydroloyzed whey protein infant formula in children with cow's milk allergy.The second study objective is to assess the long-term effects on growth and tolerance…

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.

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…