A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05879523

Enrollment

Registered

2023-05-30

Start date

2023-06-05

Completion date

2024-03-21

Last updated

2024-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Hypertrophic Cardiomyopathy

Brief 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

Interventions

DRUGHRS-1893

subcutaneous, single dose, multiple doses

DRUGPlacebo

subcutaneous, single dose, multiple doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

HRS-1893 compared with placebo

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF) 2. Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients). 3. Body mass index (BMI) between 19 and 28 kg/m2. 4. Normal Electrocardiogram (ECG)

Exclusion criteria

1. History of persistent tachyarrhythmia and syncope; 2. A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy); 3. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Design outcomes

Primary

Measure	Time frame
incidence of adverse event (AE), serious adverse event (SAE)	Start of Treatment to end of study (approximately 34 days)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026