Clinical trial NCT06210607: A Trial of HS-10511 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Hypertrophic Cardiomyopathy
Keywords: Cardiomyopathy
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Lead sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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)
timeFrame: Day 1 to day 8
measure: Number of participants with clinically significant change from baseline in vital signs in SAD
timeFrame: Day 1 to day 8
measure: Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
timeFrame: Day 1 to day 8
measure: Number of participants with clinically significant abnormalities in laboratory examination in SAD
timeFrame: Day 1 to day 8
measure: Number of participants with clinically significant abnormalities in physical examination in SAD
timeFrame: Day 1 to day 8
measure: 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)
timeFrame: Day 1 to Day 14
measure: Number of participants with clinically significant change from baseline in vital signs in MAD
timeFrame: Day 1 to Day 14
measure: Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
timeFrame: Day 1 to Day 14
measure: Number of participants with clinically significant abnormalities in laboratory examination in MAD
timeFrame: Day 1 to Day 14
measure: Number of participants with clinically significant abnormalities in physical examination in MAD
timeFrame: Day 1 to Day 14
Secondary outcomes:
Other outcomes:
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