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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Obstructive Hypertrophic Cardiomyopathy

Treatments: Drug: Placebo; Drug: HRS-1893

Study type: Interventional

Funder types: Industry

Identifiers

NCT05879523

HRS-1893-101

Details and patient eligibility

About

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

Enrollment: 76 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 3 patient groups, including a placebo group

HRS-1893 for single ascending dose (SAD) cohorts

Experimental group

Description:

Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893

Treatment:

Drug: HRS-1893

Placebo comparator for SAD cohorts

Placebo Comparator group

Description:

Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator

Treatment:

Drug: Placebo

HRS-1893 for multiple ascending dose (MAD) cohorts

Experimental group

Description:

Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts

Treatment:

Drug: HRS-1893