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

Shandong Suncadia Medicine Co., Ltd.76 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Obstructive Hypertrophic Cardiomyopathy

Interventions

HRS-1893DRUG

subcutaneous, single dose, multiple doses

PlaceboDRUG

subcutaneous, single dose, multiple doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

incidence of adverse event (AE), serious adverse event (SAE)

Time frame: Start of Treatment to end of study (approximately 34 days)

Data from ClinicalTrials.gov

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