Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5… (NCT07752069) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase I Clinical Study Evaluating the Relative Bioavailability of Different Formulations of HRS-5346 in Healthy Participants
China50 participantsStarted 2026-08
Plain-language summary
This study is a single center, randomized, open label crossover trial planned to include 50 healthy participants to evaluate the relative bioavailability of HRS-5346 new and old formulations in healthy participants. The experimental process includes three stages: screening period, baseline period, and administration observation period.
Who can participate
Age range
18 Years – 45 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
. Voluntary signing of ICF prior to trial initiation; full understanding of trial content, procedures, and potential AEs; willingness to strictly adhere to the protocol and complete the trial.
. Age 18-45 years (inclusive) on ICF signing date; male or female.
. Body weight ≥ 50 kg (male) or ≥ 45 kg (female); BMI between 19 and 28 kg/m² (inclusive).
. No clinically significant abnormalities in vital signs, physical examination, laboratory tests, 12-lead ECG, abdominal ultrasound, or chest X-ray (or CT), per investigator assessment; QTcF ≤ 450 ms (male) or ≤ 470 ms (female) on 12-lead ECG.
. Willingness to use effective contraception (participants and partners) from ICF signing to 2 weeks post-last dose; negative serum pregnancy test and non-lactating status for female participants.
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
Cmax
Timeframe: From before administration to one month after administration
2
AUC0-t
Timeframe: From before administration to one month after administration
3
AUC0-inf
Timeframe: From before administration to one month after administration
. Those with any clinically serious diseases judged by the investigator involving the circulatory system, endocrine system, nervous system, digestive system, respiratory system, hematology, immunology, psychiatry, and metabolic abnormalities, or other diseases or medical histories that may interfere with the trial results;
. Those with malignant tumors, or a history of malignant tumors within 5 years before screening (except for non-melanoma skin cancer that has been treated with no signs of recurrence, and resected cervical intraepithelial neoplasia);
. Those who have taken any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before screening, or who are still within 5 half-lives of the above drugs at the time of screening (whichever is longer);
. Those who plan to take medications other than the trial drug during the trial period;
. Those who have participated in any clinical trial of drugs or medical devices within 3 months before screening (participation in a clinical trial is defined as: having given informed consent for a clinical trial and having used the trial drug (including placebo) or trial medical device), and who are still within the follow-up period of a clinical study or within 5 half-lives of the trial drug at the time of screening (whichever is longer);
. Those with a suspected history of allergy to the study drug or any component of the study drug, those with allergic constitution, or those with a history of severe drug allergy;
. Those with a previous history of difficulty in blood collection or inability to tolerate venipuncture, such as those with needle phobia or blood phobia;
. Those with a previous history of gastric or intestinal surgery that, in the investigator's opinion, may affect drug absorption, or those with gastrointestinal diseases that may affect drug absorption;