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Healthy Subjects clinical trials

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NCT ID: NCT04188626 Completed - Healthy Subjects Clinical Trials

Identification of Biomarkers to Predict Driver Take-over Control Quality

ANTIDOTE
Start date: December 9, 2019
Phase: N/A
Study type: Interventional

At level 3 conditionally automated, the vehicle ensures driving and the driver disengages from driving to perform another activity independent of driving (ex: read a book, play on his phone ....). However, drivers are expected to be available to take over control for the case of system failure or limitation. This take-over control must take place in a limited time, very short, of the order of a few seconds. To take-over control of the vehicle quickly and efficiently, the driver must be, at the time of take-over, vigilant, efficient, and attentive to the environment and focused on the take-over of manual driving. Predicting the driver's reengagement capabilities to ensure that the driver will be able to take-over control of the vehicle is crucial at level 3 of autonomous driving. The objective of ANTIDOTE is to determine physiological and behavioural parameters capable of predicting the take-over quality in level 3 conditionally automated vehicles in a simulated highway driving situation in healthy drivers or drivers with attention disorders.

NCT ID: NCT04183491 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interferon Beta-1A Products

Start date: February 28, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.

NCT ID: NCT04183192 Completed - Healthy Subjects Clinical Trials

Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists

Start date: February 17, 2020
Phase: Phase 1
Study type: Interventional

This study is designed to assess pharmacokinetics and pharmacodynamics of mepolizumab and reslizumab across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 72 healthy subjects assigned to one of four dose groups (low, intermediate low, intermediate high, and high) of each drug (mepolizumab or reslizumab) or placebo.

NCT ID: NCT04164719 Completed - Healthy Subjects Clinical Trials

Dose-Proportionality and Food Effect Study of TNX-102 SL

Start date: October 14, 2019
Phase: Phase 1
Study type: Interventional

This will be a single center, single-dose, randomized, open-label, 3-period, crossover, dose-proportionality and food-effect study.

NCT ID: NCT04158102 Completed - Healthy Subjects Clinical Trials

Evaluate the Pharmacokinetics and Safety of EXPAREL® Following Subcutaneous Administration in Healthy Chinese Subjects

Start date: November 7, 2019
Phase: Phase 1
Study type: Interventional

This is a single-center, open-label, single-dose study to evaluate the safety, pharmacokinetics in healthy subjects

NCT ID: NCT04150224 Completed - Healthy Subjects Clinical Trials

Safety, Tolerability, Pharmacokinetics and Food Effects Study of PBTZ169

Start date: July 3, 2018
Phase: Phase 1
Study type: Interventional

Open-label prospective non-comparative ascending dose randomized cohort study of single and multiple oral administration of PBTZ169 (capsules 80 mg) in healthy volunteers

NCT ID: NCT04146129 Completed - Healthy Subjects Clinical Trials

A Phase 1 Study of CDX-0159

Start date: October 29, 2019
Phase: Phase 1
Study type: Interventional

This is a study to determine the safety of CDX-0159 in healthy subjects.

NCT ID: NCT04123288 Completed - Healthy Subjects Clinical Trials

A Study to Compare a Single-dose of Two Different Formulations of ACT-709478 in Healthy Men

Start date: December 16, 2019
Phase: Phase 1
Study type: Interventional

This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the pharmacokinetics of 2 different formulations of ACT-709478 in healthy male participants. The participants will be treated in a crossover design with 2 different treatment periods. Pharmacokinetics (PK) is the study of the absorption and breakdown of the study drug in the body. The duration of participation in this study is approximately 8 weeks from screening to the end of study visit. A screening visit is required within 21 to 3 days prior to the start of the study to determine whether the participant qualifies and is willing to enter in this research study. This study requires the participant to have two in-patient stays in the research clinic. Each in-patient stay is planned for 5 days (4 nights). Eleven days after each dose the participant will have an examination. There will be an in-between period (i.e., time between the end of period 1 and study treatment administration in Period 2) of 7 to 14 days. A safety follow-up telephone call for all participants who have received at least one study treatment will take place 30 to 40 days after the end of study examination or study discontinuation.

NCT ID: NCT04099225 Completed - Healthy Subjects Clinical Trials

Multiple Breath Washout (MBW) Using Sulfur Hexafluoride Reference Values and Influence of Anthropometric Parameters

Start date: August 2015
Phase:
Study type: Observational

Multiple breath washout (MBW) using Sulphur hexafluoride (SF6) has the potential to reveal ventilation heterogeneity in obstructive lung disease which is frequent in patients with small airway disease. However, it is missed by commonly used tests with reference data being scarce and mostly restricted to younger collectives. We aimed to evaluate the influence of anthropometric parameters on SF6-MBW reference values in pulmonary healthy adults.

NCT ID: NCT04096157 Completed - Healthy Subjects Clinical Trials

A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants

Start date: September 24, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this study is to evaluate the bioequivalence of isavuconazole following a single dose of isavuconazonium sulfate intravenous (IV) solution via nasogastric (NG) tube (test formulation) compared to a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants)(reference formulation). In addition, this study will evaluate the safety and tolerability of isavuconazole and the general pharmacokinetic (PK) parameters of isavuconazole when administered as a single dose of isavuconazonium sulfate IV solution via NG tube (test formulation) and a single dose of isavuconazonium sulfate capsules for oral administration (i.e., oral capsules administered to nonintubated participants) (reference formulation) under fasting conditions in healthy male and female participants.