A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects
NCT ID: NCT07272330
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
38 participants
INTERVENTIONAL
2025-12-11
2026-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HRS-1893 tablet A and HRS-1893 tablet B Group
HRS-1893 tablet A
Specified dose on specified days.
HRS-1893 tablet B
Specified dose on specified days.
HRS-1893 tablet B Group
HRS-1893 tablet B
Specified dose on specified days.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
HRS-1893 tablet A
Specified dose on specified days.
HRS-1893 tablet B
Specified dose on specified days.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and \<90.0 kg for men, and ≥45.0 kg and \<90.0 kg for women.
3. No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment.
4. No clinically significant abnormalities on the 12-lead ECG.
5. The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Exclusion Criteria
2. The subject has a history of syncope.
3. Exclusion due to blood pressure: Systolic Blood Pressure (SBP) \>140 mmHg or \<90 mmHg; OR Diastolic Blood Pressure (DBP) \>90 mmHg or \<60 mmHg, as determined by the investigator to be clinically significant.
4. History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
5. A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag).
6. Subjects who meet any of the following criteria will be excluded: (1) Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening. (2) Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits). (3) Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration. (4) Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse.
7. History of substance abuse.
8. Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded.
9. Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shandong Suncadia Medicine Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yang Lin
Role: primary
Shan Jing
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HRS-1893-106
Identifier Type: -
Identifier Source: org_study_id