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

Primary Purpose

Obstructive Hypertrophic Cardiomyopathy

Status

Recruiting

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HRS-1893

Placebo

About this trial

This is an interventional treatment trial for Obstructive Hypertrophic Cardiomyopathy

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF) Male or female aged 18-55（adult healthy volunteers）or 18-85 (oHCM patients). Body mass index (BMI) between 19 and 28 kg/m2. Normal Electrocardiogram (ECG) Exclusion Criteria: History of persistent tachyarrhythmia and syncope; A history of stomach or bowel surgery or excision (e.g. appendectomy, hernia repair, and/or cholecystectomy); Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

HRS-1893 for single ascending dose (SAD) cohorts

Placebo comparator for SAD cohorts

HRS-1893 for multiple ascending dose (MAD) cohorts

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05879523

First Posted

May 18, 2023

Last Updated

September 13, 2023

Sponsor

Shandong Suncadia Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05879523

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

June 5, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shandong Suncadia Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Hypertrophic Cardiomyopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

HRS-1893 compared with placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

106 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HRS-1893 for single ascending dose (SAD) cohorts

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo comparator for SAD cohorts

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

HRS-1893 for multiple ascending dose (MAD) cohorts

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

HRS-1893

Intervention Description

subcutaneous, single dose, multiple doses

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

subcutaneous, single dose, multiple doses

Primary Outcome Measure Information:

Title

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

Time Frame

Start of Treatment to end of study (approximately 34 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaoyi Sun

Phone

+86 0518-82342973

xiaoyi.sun@hengrui.com

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng Qi

Phone

+86 0518-82342973

sheng.qi@hengrui.com

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yang Lin

First Name & Middle Initial & Last Name & Degree

Shan Jing

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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