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

Obstructive Hypertrophic Cardiomyopathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879523
• Other study ID #: HRS-1893-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 5, 2023
• Est. completion date: June 2024

Study information

• Verified date: May 2023
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: Xiaoyi Sun
• Phone: +86 0518-82342973
• Email: xiaoyi.sun[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy
• Obstructive Hypertrophic Cardiomyopathy

Intervention

Drug:
• HRS-1893
subcutaneous, single dose, multiple doses
• Placebo
subcutaneous, single dose, multiple doses

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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