A Trial of HRS-1893 in Healthy Volunteers and Patients With Obstructive Hypertrophic Cardiomyopathy
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
1 other identifier
interventional
76
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2023
CompletedFirst Posted
Study publicly available on registry
May 30, 2023
CompletedStudy Start
First participant enrolled
June 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2024
CompletedOctober 30, 2024
October 1, 2024
10 months
May 18, 2023
October 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
incidence of adverse event (AE), serious adverse event (SAE)
Start of Treatment to end of study (approximately 34 days)
Study Arms (3)
HRS-1893 for single ascending dose (SAD) cohorts
EXPERIMENTALSubjects will be assigned to one of 6 planned dose cohorts and receive single dose of HRS-1893
Placebo comparator for SAD cohorts
PLACEBO COMPARATORSubjects 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
EXPERIMENTALSubjects will receive multiple doses of 2-4 planned dose cohorts and receive single dose of placebo comparator for MAD cohorts
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2023
First Posted
May 30, 2023
Study Start
June 5, 2023
Primary Completion
March 21, 2024
Study Completion
March 21, 2024
Last Updated
October 30, 2024
Record last verified: 2024-10