A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Su… (NCT07272330) | Clinical Trial Compass
CompletedPhase 1
A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects
China38 participantsStarted 2025-12-11
Plain-language summary
This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects aged 18 to 55 years (inclusive), regardless of gender.
. 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.
. 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.
. No clinically significant abnormalities on the 12-lead ECG.
. The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peak concentration (Cmax)
Timeframe: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
2
Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)
Timeframe: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
3
Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)
Timeframe: From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.
. Subjects with suspected hypersensitivity to the investigational drug or any excipient.
. The subject has a history of syncope.
. 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.
. History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
. 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).
. 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.
. History of substance abuse.
. 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.