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A Randomized, Double Blind, Single Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of ONS-3010 (Adalimumab, Oncobiologics, Inc.) Compared to Two Reference Products of Humira® (Abbvie) in Healthy Adult Subjects

Primary ObjectiveTo demonstrate pharmacokinetic comparability of ONS-3010 (Oncobiologics), US-licensed Humira®, and EU-licensed Humira® following a single 40-mg subcutaneous (SC) dose in healthy adult subjects.Secondary ObjectiveTo evaluate the…

Evaluation of Pharmacokinetics, Relative Bioavailability, and Safety of PA-101 in Healthy Subjects, Patients with Systemic Mastocytosis, and Patients with Allergic Asthma

To evaluate the plasma pharmacokinetic properties and safety of the research medication in healthy volunteers and in Patients with Systemic Mastocytosis and Allergic Asthma.

Transplantation of faeces in ulcerative colitis; restoring nature*s homeostasis

Primary objective: to study the effect of faecal transplantation in a phase II randomised placebo controlled design on simple clinical colitis activity index (SCCAI) and endoscopic Mayo score. Secondary objective: to study intra individual changes…

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…

*Fragrance allergy and skin tolerability to essential oils*

Primary Objective: What is the frequency of positive patch test reactions to the 26 declarable fragrance allergens in fragrance mix I and/or II positive participants?Secondary Objectives: Do Weleda cosmetic products containing essential oils,…

'Specialist Infant Formulas for Non-IgE mediated Cow's Milk Allergy' study

Our primary objective is to compare the clinical outcome (time to and grade of symptom resolution) after 4-week-use of a whey based extensively hydrolysed formula (eHF) versus an amino acid-based formula (AAF) in children with nIgE-CMA. As secondary…

A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to
Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with
Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or
Branebrutinib Treatment Followed by Open-label Abatacept Treatment in
Subjects with Active Rheumatoid Arthritis.

pSS: • To compare the efficacy of branebrutinib with PBO at Week 24 in the treatment of subjects with pSS• To compare the safety and tolerability of branebrutinib with PBO in subjects with pSSRA: • To compare the efficacy of branebrutinib with PBO…

A Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE)

PrimaryTo evaluate the long-term safety and tolerability of baricitinib in patients with SLE.

A single dose, randomised, double-blind parallel group study to compare the pharmacokinetics and pharmacodynamics of PB006 with Tysabri® in healthy subjects

The sponsor is developing a compound (PB006) similar to Tysabri® (natalizumab, hereafter referred to as Tysabri). As part of medical-scientific studies to confirm the similarity of the two compounds, the Sponsor wants to compare PB006 with EU-…