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Filter by:The purpose of this clinical trial is to learn about the pharmacokinetics and safety of a drug called zavegepant from samples collected using a patient-centric device called Tasso-Plus (for liquid blood sample collection) and Tasso-M20 (for dried blood sample collection) compared to standard venous sample collection. This study consists of two periods and will enroll approximately 14 healthy participants. In period 1, half of the enrolled participants (n=7) will use Tasso-Plus, and the other 50% (n=7) will use Tasso-M20. For each participant, PK samples will be collected after zavegepant administration in period 1 using the assigned Tasso device simultaneously with collecting venous blood samples. In addition, taste assessments will be performed at time intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant IN administration. Also, if feasible, 4 Japanese participants will be enrolled among those 14 participants to evaluate the PK and safety of zavegepant IN in Japanese vs. non Japanese participants. In period 2, a butterscotch candy will be given 5 minutes before administering the zavegepant IN study intervention. Taste assessment will also be performed after zavegepant IN administration with a butterscotch candy in period 2. For taste assessment, each participant will record the sensory attributes at timed intervals of 1 (immediately after dosing), 5, 10 and 20 minutes after zavegepant administration in each period. The expected duration of participation from screening until follow-up telephone contact is approximately 9 weeks.
This is a phase 1, randomised, first-in-human, double-blinded, placebo-controlled, SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) study to assess the PK, safety, and tolerability of XH-S003 in healthy volunteers. In addition, this study evaluates the effects of food on XH-S003 under a two-period, cross-over study setting.
Sometimes, it is necessary to re-learn a previously learned movement behavior, for example, a bad posture during the golf drive or while playing the piano. Unlearning or relearning an intensively trained behavior is particularly important if the behavior is hampering recovery, for example, in chronic pain or after a stroke. With this pilot study, the brain mechanisms that control the change of pre-existing stable memories of a motor skill will be tested with electroencephalography (EEG). Non-invasive brain stimulation will be used to modulate these brain mechanisms and test if it is possible to change the pre-existing motor memory and the learning of a new motor skill.
The single rising dose (SRD) part of the trial investigates safety, tolerability, and pharmacokinetics of BI 3000202. The food effect (FE) part is conducted to assess the effect of food on the relative bioavailability of the BI 3000202 formulation.
Even though extensive research on the multisensory integration of auditory and visual stimuli has been carried out, the mechanisms of integration of tactile stimuli with other senses remain less known and understood. Furthermore, the brain mechanisms associated with active and dynamic tactile exploration of a surface have not been extensively studied. In the context of the development of human-computer interaction (HCI) technologies, understanding these mechanisms remains of vital importance for the realization of multisensory devices and to improve the user experience of the general population, but also to benefit the use by clinical populations, e.g., people with visual impairments. The planned experiment aims to study multisensory integration during the active and dynamic tactile exploration of a surface (a natural texture or the screen of a multisensory tactile device). The primary hypotheses are that simultaneous auditory and/or visual stimulation during active tactile exploration of a surface will help participants form a mental representation of the shape or texture they are exploring, and that the recorded brain activity will be compatible with multisensory integration mechanisms at the level of the cerebral cortex. The planned project will include (1) behavioral (psychophysical) experiments, to assess participants' performance in discriminating the spatio-temporal location of tactile, auditory, visual, audio-tactile, audio-visual, and audio-visual-tactile on the screen of a multisensory tactile device and (2) surface electroencephalography (EEG) recording experiments, which will be employed to study the cortical mechanisms of multisensory integration during active and dynamic tactile exploration .
Using magnetic resonance (MR) imaging or spectroscopy as part of clinical research typically involves developing new MR protocols. Although some of this work is done by scanning artificial 'phantoms', volunteer studies are normally needed to configure and validate new protocols appropriately. Developing new MR protocols and techniques is also useful in its own right. The volunteer scanning described in this application will provide data to support this type of methodological research into new scanning and image processing techniques: improving the speed, quality, and range of measurements possible with the scanner. With proper safety and screening procedures, MR has no known side-effects, and has been performed on millions of human subjects worldwide without ill effect. There are well-established contraindications for MRI, and screening procedures are already in place in the MR unit at UCLH to exclude such subjects and ensure the safety of subjects. With these, and the MR scanner's built in safety mechanisms, residual risk is low. Many other trusts with active MR research have previously made similar applications to this related to volunteer MR scanning for pilot work and methodological research Although scans may obtained as part of several research projects, in each case it is only the scanning technique (the programmed sequence of data acquisition and processing steps) which will vary, along with the body region to be imaged. The volunteer experience will be very similar, and all ethical issues, including the information sheet and consent form, will be identical. These scans are for methodological research on the MR techniques themselves, and will be never form part of the volunteer's own healthcare. Separate ethical permission is sought for any study which does not match the above criteria.
This study is a phase 1 single dose escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability,pharmacokinetics and Pharmacodynamics of SHR-2001 in healthy subjects
This is a prospective, placebo controlled study, examining the effects of dietary supplement's effects on cognition and confirming safety.
The purpose of the study is to assess the safety and tolerability of single and multiple oral doses of Hemay005 tablets in healthy Caucasian adult volunteers.
This study will assess the safety, tolerability and pharmacokinetics(PK) of Y-2 sublingual tablet in healthy adult subjects.