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

• Sponsor: Shandong Suncadia Medicine Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05879523
• Collaborator: (none)
• Enrollment: 98
• Arms: 3
• Anticipated Duration (Months): 13

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Obstructive Hypertrophic Cardiomyopathy	Drug: HRS-1893; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 98 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: HRS-1893 compared with placeboHRS-1893 compared with placebo
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: May 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: HRS-1893; subcutaneous, single dose, multiple doses
Placebo Comparator: Placebo comparator for SAD cohorts Subjects will be assigned to one of 6 planned dose cohorts and receive single dose of placebo comparator	Drug: Placebo; subcutaneous, single dose, multiple doses
Experimental: 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	Drug: HRS-1893; subcutaneous, single dose, multiple doses

Outcome Measures

Primary Outcome Measures

1. incidence of adverse event (AE), serious adverse event (SAE) [Start of Treatment to end of study (approximately 34 days)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shandong Suncadia Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shandong Suncadia Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05879523
• Other Study ID Numbers: HRS-1893-101
• First Posted: May 30, 2023
• Last Update Posted: May 30, 2023
• Last Verified: May 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy

Study Results

No Results Posted as of May 30, 2023