Hypertrophic Cardiomyopathy Clinical Trial
Official title:
A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of HS-10511 in Healthy Subjects
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and pharmacodynamic (PK) and pharmacodynamic (PD) characteristics of HS-10511 when administered as single oral dose and multiple oral doses in healthy adult subjects.
This study is a phase I, randomized, double-blind, placebo-controlled clinical trial evaluating the safety, tolerability, and PK and PD characteristics of HS-10511 in healthy adult subjects. This study consists of two parts: Part 1 is a single ascending dose (SAD) peroid in healthy subjects and Part 2 is a multiple ascending dose (MAD) period. Each period is composed of the screening, baseline, dosing and observation, and follow-up periods. All subjects will sign a written informed consent form (ICF) and will be assessed for eligibility criteria before entering the screening period (D-28-D-1). Subjects who meet all inclusion criteria and none of the exclusion criteria will be admitted in the baseline period (i.e., 1 day before dosing, D-1), undergo baseline assessment and randomization, complete dosing and the safety, tolerability, and PK and PD assessments within the given time period, and complete outpatient visits at the given follow-up time after discharge. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03249272 -
Microvascular Dysfunction in Nonischemic Cardiomyopathy: Insights From CMR Assessment of Coronary Flow Reserve
|
Phase 4 | |
| Recruiting |
NCT03846297 -
Optimisation of Decision Making for Defibrillator Implantation in Hypertrophic Cardiomyopathy
|
||
| Completed |
NCT02806479 -
Hypertrophic Cardiomyopathy Pilot Study
|
||
| Active, not recruiting |
NCT01225978 -
Refining Information Technology Support for Genetics in Medicine
|
N/A | |
| Completed |
NCT00001632 -
Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease
|
N/A | |
| Completed |
NCT00001534 -
Long Term Effects of Enalapril and Losartan on Genetic Heart Disease
|
N/A | |
| Enrolling by invitation |
NCT04050579 -
OPIE in the Thin Interventricular Septum
|
N/A | |
| Completed |
NCT03537183 -
Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy?
|
N/A | |
| Completed |
NCT02590809 -
Hypertrophic Cardiomyopathy Symptom Release by BX1514M
|
Phase 2 | |
| Completed |
NCT00001396 -
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
|
Phase 1 | |
| Active, not recruiting |
NCT03723655 -
A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM
|
Phase 2/Phase 3 | |
| Completed |
NCT05135871 -
Study Evaluating the Pharmacokinetics of Mavacamten in Healthy Adult Chinese Subjects
|
Phase 1 | |
| Completed |
NCT04129905 -
Assessment of the Relations Between Endothelial and Venous Dysfunctions and Left Ventricular Obstruction in Genetic Hypertrophic Cardiomyopathies
|
N/A | |
| Recruiting |
NCT03061994 -
Metabolomic Study of All-age Cardiomyopathy
|
N/A | |
| Completed |
NCT02234336 -
Assessment of Wall Thickness in Hypertrophic Cardiomyopathy
|
||
| Recruiting |
NCT00221832 -
Molecular Genetic Screening and Identification of Congenital Arrhythmogenic Diseases
|
N/A | |
| Not yet recruiting |
NCT03706001 -
Efficacy of Psychotherapy for Improving Quality of Life in Patients With Hypertrophic Cardiomyopathy and Depression
|
N/A | |
| Recruiting |
NCT06169358 -
Screening Patients With Fabry Disease in Patients With Hypertrophic Cardiomyopathy or Left Ventricular Hypertrophy
|
||
| Not yet recruiting |
NCT04090437 -
HCM-AF Ablation With ACUTUS
|
N/A | |
| Completed |
NCT04402268 -
Efficacy of Risk Assessment for Sudden Cardiac Death in Patients With Hypertrophic Cardiomyopathy
|