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NCT ID: NCT03198013 Completed - Immunoscience Clinical Trials

A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

Start date: November 11, 2008
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects

NCT ID: NCT03197935 Not yet recruiting - Clinical trials for Triple-negative Breast Cancer

A Study to Investigate Atezolizumab and Chemotherapy Compared With Placebo and Chemotherapy in the Neoadjuvant Setting in Participants With Early Stage Triple Negative Breast Cancer

Start date: July 31, 2017
Phase: Phase 3
Study type: Interventional

This is a global Phase III, double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of neoadjuvant treatment with atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) and nab-paclitaxel followed by doxorubicin and cyclophosphamide (nab-pac-AC), or placebo and nab-pac−AC in participants eligible for surgery with initial clinically assessed triple-negative breast cancer (TNBC).

NCT ID: NCT03197766 Enrolling by invitation - Achondroplasia Clinical Trials

A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

Start date: December 12, 2016
Phase: Phase 3
Study type: Interventional

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.

NCT ID: NCT03196765 Not yet recruiting - Clinical trials for X-linked Adrenoleukodystrophy

Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy

Start date: October 1, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This is a phase I/II, open label dose escalation study of multiple dose levels of NV1205 with a long-term treatment phase.

NCT ID: NCT03194139 Not yet recruiting - Healthy Clinical Trials

A Study Designed to Compare the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 and GC4419 in Healthy Volunteers

Start date: September 2017
Phase: Phase 1
Study type: Interventional

The study will be a double-blind, randomized, crossover, single-dose assessment of IV-administered GC4711 compared to GC4419 in healthy volunteers. Consenting subjects will undergo screening procedures within 28 days of the start of dosing. Pharmacokinetics (parent drug and major metabolites) will be assessed in plasma and urine from all subjects. Initially, a sentinel cohort of 4 subjects, will be enrolled; each eligible subject will receive single dose of GC4711 IV at dose of 30 mg over one hour. Following a clinical safety review by the Galera study team , if no safety concerns are identified after the last subject completes study participation, enrollment will continue in 2 stages to a crossover study design. In stage 1, 12 subjects will be enrolled and in stage 2, if no safety concerns are identified in stage 1 following a clinical safety review by the Galera study team, 20 subjects will be enrolled. In both enrollment stages, eligible subjects in the crossover design will be randomized in 1:1 ratio to one of two treatment sequences: Test (GC4711) -> Ref (GC4419) or Ref (GC4419) -> Test (GC4711). On Day 1, subjects will receive the first treatment they were randomized to, and on Day 4 (following a washout), they will receive the second treatment. Subjects will be followed up for 2 days after the second treatment.

NCT ID: NCT03192969 Not yet recruiting - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT03192280 Not yet recruiting - Skin Inflammation Clinical Trials

Skin IaM: An Exploratory Clinical Trial to Evaluate Changes in Skin Appearance, Colour, and/or Texture Following the Induction of a Local Inflammatory Skin Response

Start date: June 19, 2017
Phase: N/A
Study type: Interventional

This trial will test the feasibility of various imaging devices to detect local skin inflammation prior to clinical manifestation.

NCT ID: NCT03191799 Not yet recruiting - Hemophilia A Clinical Trials

A Study to Evaluate the Safety and Tolerability of Prophylactic Emicizumab in Hemophilia A Patients With Inhibitors

Start date: July 27, 2017
Phase: Phase 3
Study type: Interventional

This is a phase IIIb, single arm, open-label, multi-center study to evaluate the safety and tolerability of emicizumab in participants with congenital hemophilia A who have documented inhibitors against Factor VIII (FVIII) at enrollment. Approximately 200 participants, aged 12 or older, will be enrolled in this study and are expected to be enrolled at approximately 85 sites globally. Participants will receive an initial weekly dose of prophylactic emicizumab subcutaneously for 4 weeks, followed by a weekly maintenance dose subcutaneously for the remainder of the 2-year treatment period.

NCT ID: NCT03189173 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

Start date: July 2017
Phase: Phase 2
Study type: Interventional

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested: Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance. Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.

NCT ID: NCT03189017 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

A Phase I Study of ICP-022 in Subjects

Start date: July 4, 2017
Phase: Phase 1
Study type: Interventional

This is a single center, randomized, double-blind, placebo-controlled, dose escalation study in healthy subjects to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ICP-022 following oral single and multiple escalating dose administration.