NCT05879523CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 30 Oct 2024
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 76 (actual)
- First submitted
- 18 May 2023
- Start date
- 5 Jun 2023
- Primary completion date
- 21 Mar 2024
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Diseases
- Hypertrophic cardiomyopathy
- NCT number
- NCT05879523
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 76
- From 5 Jun 2023 to the primary completion date, 21 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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)
Age in the registry: 18 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Anzhen Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.