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

Phase 1

Completed

• Conditions: Obstructive Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893; Drug: Placebo

• Registration Number: NCT05879523
• Lead Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-18
• Study First Submitted QC: 2023-05-18
• Study First Posted: 2023-05-30
• Study Start: 2023-06-05
• Primary Completion: 2024-03-21
• Study Completion: 2024-03-21
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-29
• Last Update Posted: 2024-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HRS-1893 for single ascending dose (SAD) cohorts	HRS-1893	Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893
Placebo comparator for SAD cohorts	Placebo	Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator
HRS-1893 for multiple ascending dose (MAD) cohorts	HRS-1893	Subjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts

Primary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China