A Trial of HS-10511 in Healthy Subjects

NCT06210607 | Unknown Phase 1

• 1 other identifier: HS-10511-101
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

Cardiomyopathy; Hypertrophy; Heart Diseases; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (10)

• The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in single ascending dose (SAD)

  The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.

  Day 1 to day 8

• Number of participants with clinically significant change from baseline in vital signs in SAD

  Day 1 to day 8

• Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD

  Day 1 to day 8

• Number of participants with clinically significant abnormalities in laboratory examination in SAD

  Day 1 to day 8

• Number of participants with clinically significant abnormalities in physical examination in SAD

  Day 1 to day 8

• The incidence and severity of adverse events (AE), serious adverse events (SAE) and adverse events leading to withdrawal from the trial and the correlation with the investigational drug in multiple ascending dose (MAD)

  The definition of adverse event \[AE\] is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The definition of serious adverse event \[SAE\] is any untoward medical occurrence at any dose that results in death; is life threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; results in congenital anomaly/birth defect.

  Day 1 to Day 14

• Number of participants with clinically significant change from baseline in vital signs in MAD

  Day 1 to Day 14

• Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD

  Day 1 to Day 14

• Number of participants with clinically significant abnormalities in laboratory examination in MAD

  Day 1 to Day 14

• Number of participants with clinically significant abnormalities in physical examination in MAD

  Day 1 to Day 14

Study Arms (2)

HS-10511 Tablets

EXPERIMENTAL

Subjects will be assigned to one of 5\~6 planned dose cohorts in (single ascending dose)SAD and one of 4 planned dose cohorts in (multiple ascending dose)MAD.

Drug: HS-10511 Tablets

HS-10511 Tablets Placebo

PLACEBO COMPARATOR

Subjects will be assigned to one of 5\~6 planned dose cohorts in SAD and one of 4 planned dose cohorts in MAD.

Drug: HS-10511 Tablets Placebo

Interventions

HS-10511 Tablets DRUG

HS-10511 tablets for 5\~6 SAD cohorts and 4 MAD cohorts

HS-10511 Tablets

HS-10511 Tablets Placebo DRUG

HS-10511 tablets placebo for 5\~6 SAD cohorts and 4 MAD cohorts

HS-10511 Tablets Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: No less than 1/3 of either gender
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females aged 18-45 years (inclusive) at screening;
• Body weight ≥ 50 kg in males and ≥ 45 kg in females, and body mass index (BMI): 18.0-27.9 kg/m2 (inclusive) at screening;
• Acoustic windows are adequate for performing precise transthoracic echocardiography;
• Normal cardiac structure and function as determined by a cardiologist, or presence of clinically irrelevant abnormalities at the discretion of a cardiologist or ultrasound specialists;
• Normal clinical laboratory test results at screening and admission to the clinical study site, or presence of clinically irrelevant abnormalities at the discretion of the investigator;
• Able to understand and agree to sign the ICF, and to agree to follow all study procedures and restrictions (including remaining at the study site within the time period defined in the schedule of assessments);
• Willing to and able to perform normal non-vigorous physical activities starting from 48 h before D-1, during the admission to the study site, and even during the study period;
• Able to sufficiently understand the study content, process, and potential adverse reactions, and voluntarily sign the ICF.

You may not qualify if:

• Those with possibly clinically relevant diseases are not suitable for participating in this study as assessed by the investigator at screening;
• Previous history of syncope, history of clinically significant cardiac disease including;
• Presence of a medical history of malignancy of any type within 5 years before screening;
• Consumption of caffeine-and/or xanthine-rich food or beverages (e.g., coffee, tea, chocolate, and caffeine-containing carbonated beverages such as cola), tobacco-containing products (e.g., cigarettes), and alcohol or alcoholic products within 48 h before dosing;
• Consumption of grapefruit, grapefruit juice, seville orange, seville orange jam, and seville orange juice or other grapefruit- or seville orange-containing products within 7 days before the first dose;
• Positive breath alcohol test or presence of a history of heavy smoking or alcoholism within 6 months before screening: heavy smoking (more than 5 cigarettes or the equivalent amount of tobacco per day); alcoholism (≥ 14 units of alcohol per week: 1 unit = 285 mL of beer, 25 mL of spirits with an alcohol by volume of ≥ 40%, or 150 mL of wine);
• Positive urine drug test or abuse of barbiturates, amphetamines, benzodiazepines, cocaine, opiates, marijuana, methadone, phencyclidine, and tricyclic antidepressants or methamphetamines, or other situation that is unfit to participate in the study judged by the researcher;
• Subject has a positive serum β-human chorionic gonadotropin (β-hCG) test at screening, or is in pregnancy, or is in lactation;
• Presence of clinically relevant gastrointestinal complaints, a history of gastrointestinal diseases (e.g., Crohn's disease, and ulcerative colitis), or a history of surgeriesthat may affect the absorption of the investigational drug within 7 days before the first dose;
• Those with a history of any serious drug hypersensitivity, allergic diseases (e.g., asthma, severe urticaria, and severe allergic rhinitis), or other allergic constitutions are not suitable for participating in this study at the discretion of the investigator;
• Other conditions or causes that make subjects unsuitable for participating in this clinical study, as determined by the investigator.

Sponsors & Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Cardiomyopathies; Hypertrophy; Heart Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yu Zhang

CONTACT

010-82266876; bysyec@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 31, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 18, 2024

Record last verified: 2024-01