Hypertrophic CardiomyopathyPhase 1NCT06210607
A Trial of HS-10511 in Healthy Subjects
A Phase 1 study testing HS-10511 Tablets in people with Hypertrophic Cardiomyopathy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- HS-10511 Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2024to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- HS-10511 Tablets, HS-10511 Tablets Placebo
- Keywords
- Cardiomyopathy, Hypertrophy, Heart Diseases, Cardiovascular Diseases
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Cardiomyopathies, Hypertrophy, Heart Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-10511 TabletsDrug
HS-10511 tablets for 5~6 SAD cohorts and 4 MAD cohorts
HS-10511 Tablets PlaceboDrug
HS-10511 tablets placebo for 5~6 SAD cohorts and 4 MAD cohorts
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: HS-10511 Tablets Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 to day 8
Number of participants with clinically significant change from baseline in vital signs in SAD
Measured: Day 1 to day 8
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
Measured: Day 1 to day 8
Number of participants with clinically significant abnormalities in laboratory examination in SAD
Measured: Day 1 to day 8
Number of participants with clinically significant abnormalities in physical examination in SAD
Measured: 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.
Measured: Day 1 to Day 14
Number of participants with clinically significant change from baseline in vital signs in MAD
Measured: Day 1 to Day 14
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
Measured: Day 1 to Day 14
Number of participants with clinically significant abnormalities in laboratory examination in MAD
Measured: Day 1 to Day 14
Number of participants with clinically significant abnormalities in physical examination in MAD
Measured: Day 1 to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start31 Jan 2024 (estimated)
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Jiangsu Hansoh Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210607
- Sponsor's protocol ID
- HS-10511-101
- Status last verified
- Jan 2024
- First submitted
- 8 Jan 2024
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06210607
- Acronym / sponsor ID
- HS-10511-101
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- Cardiomyopathy, Hypertrophy, Heart Diseases, Cardiovascular Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (estimated)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HS-10511 Tablets | Experimental | Drug: HS-10511 TabletsSubjects 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. |
| HS-10511 Tablets Placebo | Placebo comparator | Drug: HS-10511 Tablets PlaceboSubjects will be assigned to one of 5~6 planned dose cohorts in SAD and one of 4 planned dose cohorts in MAD. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-10511 TabletsHS-10511 tablets for 5~6 SAD cohorts and 4 MAD cohorts | Drug | HS-10511 Tablets |
| HS-10511 Tablets PlaceboHS-10511 tablets placebo for 5~6 SAD cohorts and 4 MAD cohorts | Drug | HS-10511 Tablets Placebo |
Primary outcome
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)
Time frame: Day 1 to day 8
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.
Number of participants with clinically significant change from baseline in vital signs in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant abnormalities in laboratory examination in SAD
Time frame: Day 1 to day 8
Number of participants with clinically significant abnormalities in physical examination in SAD
Time frame: 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)
Time frame: Day 1 to Day 14
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.
Number of participants with clinically significant change from baseline in vital signs in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) findings in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant abnormalities in laboratory examination in MAD
Time frame: Day 1 to Day 14
Number of participants with clinically significant abnormalities in physical examination in MAD
Time frame: Day 1 to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HS-10511 Tablets in people with Hypertrophic Cardiomyopathy, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang (010-82266876, bysyec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Day 1 to day 8). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.