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NCT ID: NCT03636347 Completed - COPD Clinical Trials

A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo.

ASTRAEUS
Start date: October 29, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the effect of alvelestat (an oral neutrophil elastase inhibitor) on blood and sputum biomarkers in patients with PiZZ, null or rare variant phenotype/genotype alpha-1 anti-trypsin deficient lung disease. Change in a number of different blood and sputum biomarkers related to lung damage, inflammation and elastase activity will be measured over a 12 week period. The effect on lung function and respiratory symptoms will also be measured.

NCT ID: NCT03636269 Completed - Uremic Pruritus Clinical Trials

CR845-CLIN3103: A Global Study to Evaluate the Safety and Efficacy of CR845 in Hemodialysis Patients With Moderate-to-Severe Pruritus

KALM-2
Start date: July 17, 2018
Phase: Phase 3
Study type: Interventional

This is a multicenter, international study to evaluate the safety and efficacy of intravenous (IV) CR845 at a dose of 0.5 mcg/kg administered after each dialysis session. The study includes a 12-week randomized, double-blind, placebo-controlled Phase and a 52-week Open-label Extension Phase.

NCT ID: NCT03636204 Completed - Healthy Clinical Trials

A First in Human Study in Healthy Volunteers and in Participants With Frontotemporal Dementia With Granulin (GRN) Mutation

Start date: September 14, 2018
Phase: Phase 1
Study type: Interventional

A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics

NCT ID: NCT03636191 Completed - Clinical trials for Infections, Upper Respiratory Tract

The Effect of a Probiotic on Upper Respiratory Tract Infections

PIP-U
Start date: September 1, 2018
Phase: N/A
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.

NCT ID: NCT03635983 Completed - Melanoma Clinical Trials

A Study of NKTR-214 Combined With Nivolumab vs Nivolumab Alone in Participants With Previously Untreated Inoperable or Metastatic Melanoma

Start date: September 21, 2018
Phase: Phase 3
Study type: Interventional

The purpose of the study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drug called NKTR-214, when combined with nivolumab versus nivolumab given alone in participants with previously untreated melanoma skin cancer that is either unable to be surgically removed or has spread

NCT ID: NCT03635086 Completed - Clinical trials for Chikungunya Virus Infection

Safety, Tolerability and Long-term Immunogenicity of Different Formulations of a Chikungunya Vaccine (V184-005)

Start date: August 22, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate immunogenicity and safety of Measles Virus-Chikungunya (MV-CHIK) vaccine in different dose regimens, 28 days after one or two vaccinations.

NCT ID: NCT03635047 Completed - Healthy Clinical Trials

A Phase I Study for Safety and Tolerability of AL002.

Start date: November 12, 2018
Phase: Phase 1
Study type: Interventional

This is a multi-centre, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AL002.

NCT ID: NCT03634085 Completed - Healthy Clinical Trials

Single Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of BDM-2 in Healthy Male Subjects.

Start date: May 17, 2018
Phase: Phase 1
Study type: Interventional

This is a first-in-human (FIH), double-blind, placebo-controlled, randomized trial in healthy adult male subjects, to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending oral doses of BDM-2. The effect of food on the PK of a single dose of BDM-2 will also be evaluated.

NCT ID: NCT03633617 Completed - Clinical trials for Eosinophilic Esophagitis

Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE)

Start date: September 24, 2018
Phase: Phase 3
Study type: Interventional

The primary objectives of the study by study part are: Part A: To determine the treatment effect of dupilumab compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures and to inform/confirm the final sample size determination for Part B. Part B: To demonstrate the efficacy of dupilumab treatment compared with placebo in adult and adolescent patients with EoE after 24 weeks of treatment as assessed by histological and clinical measures. Part C: To assess the safety and efficacy of dupilumab treatment in adult and adolescent patients with EoE after up to 52 weeks of treatment as assessed by histological and clinical measures. The secondary objectives of the study are: - To evaluate the safety, tolerability, and immunogenicity of dupilumab treatment for up to 52 weeks in adult and adolescent patients with EoE - To explore the relationship between dupilumab concentration and responses in adult and adolescent patients with EoE, using descriptive analyses - To evaluate the effects of dupilumab on transcriptomic signatures associated with EoE and type 2 inflammation - To demonstrate the efficacy of dupilumab treatment compared to placebo after 24 weeks and 52 weeks of treatment in adult and adolescent patients with EoE who have previously received swallowed topical corticosteroids

NCT ID: NCT03633591 Completed - Healthy Volunteers Clinical Trials

A Study Assessing the Safety and Pharmacokinetic Profile of Modified Release Formulations of Tolcapone

Start date: June 25, 2018
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetic profiles of tolcapone in healthy subjects after administration of one or two oral doses of multiple modified release prototype formulations.