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

NCT ID: NCT05879523

Last Updated: 2024-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2024-03-21

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

Conditions

Obstructive Hypertrophic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HRS-1893 for single ascending dose (SAD) cohorts

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

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

subcutaneous, single dose, multiple doses

Placebo comparator for SAD cohorts

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

subcutaneous, single dose, multiple doses

HRS-1893 for multiple ascending dose (MAD) cohorts

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

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

subcutaneous, single dose, multiple doses

Interventions

HRS-1893

subcutaneous, single dose, multiple doses

Intervention Type: DRUG

Placebo

subcutaneous, single dose, multiple doses

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HRS-1893-101

Identifier Type: -

Identifier Source: org_study_id