Obstructive Hypertrophic CardiomyopathyPhase 1NCT05879523
A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
A Phase 1 study testing HRS-1893 in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
Trial summary
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2023to 21 Mar 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
- Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients).
- Body mass index (BMI) between 19 and 28 kg/m2.
- Normal Electrocardiogram (ECG)
Who cannot join
- History of persistent tachyarrhythmia and syncope;
- A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
About this study
Official title: A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893, Placebo
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893Drug
subcutaneous, single dose, multiple doses
PlaceboDrug
subcutaneous, single dose, multiple doses
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 for single ascending dose (SAD) cohorts | Experimental | Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893 Receives: Drug: HRS-1893 |
| Placebo comparator for SAD cohorts | Placebo comparator | Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator Receives: Drug: Placebo |
| HRS-1893 for multiple ascending dose (MAD) cohorts | Experimental | Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts Receives: Drug: HRS-1893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of adverse event (AE), serious adverse event (SAE)
Measured: Start of Treatment to end of study (approximately 34 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start5 Jun 2023
- Primary completion21 Mar 2024
- Study completion21 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine 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
- Model description
- HRS-1893 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879523
- Sponsor's protocol ID
- HRS-1893-101
- Status last verified
- Oct 2024
- First submitted
- 18 May 2023
- Last updated
- 30 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Yang K, Liu W, Lin Y, Jing S, Sun X, Fu M, Li X, Zhang T, Hu M, He F, Feng J. Safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HRS-1893, a cardiac myosin inhibitor, in healthy subjects. Br J Clin Pharmacol. 2026 May 20. doi: 10.1002/bcp.70542. Online ahead of print.
PubMed 42160017
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effects of Food on the Pharmacokinetics of HRS-1893 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05879523
- Acronym / sponsor ID
- HRS-1893-101
- Conditions
- Obstructive Hypertrophic Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 21 Mar 2024 (actual)
- Study completion
- 21 Mar 2024 (actual)
- First posted
- 30 May 2023 (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.
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-1893 in healthy volunteers and patients with obstructive hypertrophic cardiomyopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- HRS-1893 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 for single ascending dose (SAD) cohorts | Experimental | Drug: HRS-1893Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893 |
| Placebo comparator for SAD cohorts | Placebo comparator | Drug: PlaceboSubjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator |
| HRS-1893 for multiple ascending dose (MAD) cohorts | Experimental | Drug: HRS-1893Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF)
- Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients).
- Body mass index (BMI) between 19 and 28 kg/m2.
- Normal Electrocardiogram (ECG)
Key exclusion criteria (3 listed)
- History of persistent tachyarrhythmia and syncope;
- A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy);
- Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
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 |
|---|---|---|
| HRS-1893subcutaneous, single dose, multiple doses | Drug | HRS-1893 for multiple ascending dose (MAD) cohorts, HRS-1893 for single ascending dose (SAD) cohorts |
| Placebosubcutaneous, single dose, multiple doses | Drug | Placebo comparator for SAD cohorts |
Primary outcome
incidence of adverse event (AE), serious adverse event (SAE)
Time frame: Start of Treatment to end of study (approximately 34 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2024.
- Derived from this study: PubMed 42160017Yang K, Liu W, Lin Y, Jing S, Sun X, Fu M, Li X, Zhang T, Hu M, He F, Feng J. Safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of HRS-1893, a cardiac myosin inhibitor, in healthy subjects. Br J Clin Pharmacol. 2026 May 20. doi: 10.1002/bcp.70542. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1893 in people with Obstructive Hypertrophic Cardiomyopathy, run by Shandong Suncadia Medicine Co., Ltd. at 1 site in China.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of adverse event (AE), serious adverse event (SAE) (time frame: Start of Treatment to end of study (approximately 34 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879523, which also lists 1 linked publication.
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 30 Oct 2024.