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IBIS: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-IminoBiotin in acute Ischemic Stroke due to large vessel occlusion

This study will be a prospective, placebo controlled, randomised phase 2 single centre study with the primary objective to evaluate the safety and tolerability of 2-IB when administered to patients with AIS due to LVO, treated with IVT and/or EVT.…

The effect of Galacto-oligosaccharides (GOS) on self-perceived stress in apparently healthy but stressed Dutch women: randomized controlled study

The main objective of this study is to assess the effect of GOS in combination with 2*-FL on perceived stress. The secondary objective is to assess the effect of GOS in combination with 2-FL on saliva cortisol levels, as well as on perceived anxiety…

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study To Assess The Safety, Tolerability, Pharmacokinetics Of Two Monoclonal Antibodies In Healthy Volunteers

In this study we will investigate how safe the experimental compounds AER001 and AER002 are and how well they are tolerated when they are used in healthy subjects.We also investigate how quickly and to what extent AER002 (as a single dose) and…

Postprandial amino acid uptake kinetics of barley rice proteins

In the current study we aim to measure the postprandial amino acid uptake kinetics of barley rice protein, and compare this to pea protein. A benchmark protein (whey) will be included for comparability of amino acid uptake of different protein…

The impact of milk protein glycation on protein digestion and absorption in healthy young men

To compare the appearance of dietary protein-derived amino acids in plasma after ingestion of a milk protein powder with different levels of protein glycation in healthy young men.

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL919 in Healthy Participants

To investigate the safety and tolerability of DNL919To characterize the serum PK of DNL919

Using a complex carbohydrate mixture added to a high-protein DIet to STeer fermentation to improve metabolic, gut and brain heALth

Primary Objective: The main goal of this study is to provide evidence that steering saccharolytic/proteolytic fermentation by a specific indigestible fibre mixture supplemented against the background of a high-protein diet optimizes beneficial and…

Effect of a probiotic strain on immune response to influenza vaccination

To investigate the effect of Bifidobacterium lactis CECT 8145 BPL1® on the seroconversion rate after influenza vaccination in healthy adults, compared to placebo treatment.

Multi-Centre, Placebo-Controlled, Phase 2 Study of Etripamil Nasal Spray (NS) for the Reduction of Ventricular Rate in Patients with Atrial Fibrillation

The primary objective of this study is to demonstrate the superiority of etripamil NS over placebo in reducing ventricular rate in patients with AF.

Phase 2, randomized, parallel-group, double-blind, placebo-controlled study of sonelokimab in patients with active moderate to severe hidradenitis suppurativa

Primary Objective:1. To evaluate the efficacy of sonelokimab at 2 different dose levels (120 mg, 240 mg) compared with placebo in the treatment of participants withactive moderate to severe hidradenitis suppurativa.Secondary Objectives:1. To…

A DOUBLE-BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 24 WEEKS TREATMENT WITH REN001 IN PATIENTS WITH PRIMARY MITOCHONDRIAL MYOPATHY (PMM)

Main Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by the effect on exercise endurance.Secondary Objective:To evaluate the efficacy of REN001 in subjects with PMM treated for 24 weeks, assessed by…

A First in Human, Phase 1, Randomized, Double-blind, Placebo-controlled, Single Ascending Total Daily Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Intravenous Infusion of OMN6 in Healthy Subjects

Primary objective: To evaluate the safety and tolerability of single ascending i.v. doses of OMN6 in healthy young and elderly adult subjects.Secondary objective: To evaluate OMN6 PK in plasma following single ascending i.v. doses in healthy young…

The effect of ingesting a whey and collagen protein blend on myofibrillar and connective tissue protein synthesis rates at rest and during recovery from exercise

To assess the impact of the combined ingestion of whey and collagen protein on myofibrillar and connective tissue protein synthesis rates in muscle tissue obtained at rest and during recovery from exercise in vivo in humans.

A phase 1, randomized, double-blind, placebo-controlled, multiple dose platform study investigating the immunopharmacology of EDP1815 and EDP2939

Primary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (two dose levels using EC2 capsules) on the immune system.Secondary• To evaluate the effect of EDP1815 (same dose using EC1 and EC2 capsules) and EDP2939 (…

A Clinical Evaluation of the RheOx Bronchial Rheoplasty System for the Treatment of the Symptoms of Chronic Bronchitis in Adult Patients with COPD

To assess the safety and effectiveness of Bronchial Rheoplasty for the treatment of the symptoms of chronic bronchitis in adult COPD patients with moderate to severe chronic bronchitis.

The effect of mealworm protein on muscle damage in active vital elderly

To investigate the impact of the daily consumption of a mealworm- and whey protein supplement on muscle damage upon physical exercise in vital active elderly.

A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis

This study has been transitioned to CTIS with ID 2023-509784-24-00 check the CTIS register for the current data. Core phase: The overall objective of the core phase is to investigate the efficacy, safety and tolerability of 2 dose regimens of HZN-…

A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients with Cold
Agglutinin Disease (CAD)

Primary objective:- To demonstrate the efficacy of twice-weekly s.c. 1080-mg infusions of pegcetacoplan compared with that of placebo in patients with CAD.Secondary objectives:- To demonstrate the effect of pegcetacoplan on the number of PRBC…

A Three-Part, Adaptive, Randomized, Double blind, Placebo Controlled First in Human Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Single and Multiple Ascending Oral Doses of GM-1020 and the Effect of Food on Single Dose GM-1020 in Healthy Volunteers.

To characterize the safety and tolerability of ascending single oral doses (part A) and ascending repeated oral doses (part B) of GM-1020 and the effect of food on single dose GM-1020 (part C) in healthy volunteers.

A phase 3 study of PTC923 in subjects with phenylketonuria

Primary:• To evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in subjects with phenylketonuria (PKU) as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (ie, the average of each respective…