Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With… (NCT06657560) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal Function
China41 participantsStarted 2024-10-14
Plain-language summary
This is an open-label, non-randomized, parallel cohorts design, multicenter, single dose phase I study.
The primary objectives are:
To evaluate the pharmacokinetics (plasma and urine) profile of HRS-9231 following single intravenous injection (0.05 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference.
To assess dialysability of HRS-923 following a single intravenous injection (0.05 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.
Who can participate
Age range
18 Years – 65 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
. Male or female subjects, ages 18 to 65, inclusive, at the time of informed consent.
. Female subjects weigh ≥ 45 kg, male subjects weigh ≥ 50 kg, and BMI between 18.0 and 28.0 kg/m2, inclusive, at screening.
. Have an eGFR expressed in mL/min/1.73m2 (MDRD formula estimation) at screening within the range of:
. The renal function is required to be stable. The interval between two assessments during the screening period should be at least 72 hours apart (the first renal function assessment result may use historical values with 30 days before screening), and the two assessments should be consistent with the same renal function classification and two values have to show ≤25%. If the two assessments are inconsistent in terms of renal function category, the third assessment has to be conducted at least 72 hours after the second assessment. If the second and third assessments differ, the subject will be ineligible for the study.
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: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
2
AUC0-t
Timeframe: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
3
AUC0-∞
Timeframe: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
4
Tmax
Timeframe: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
5
Ae
Timeframe: Prior to HRS-9231 administration and Day 5 (for all cohorts) or within 6 days (only for cohort D) after administration.
. Subject with any history of severe allergic or anaphylactic reactions to any allergen including drugs and contrast agents, or allergic disease diagnosed and treated by a physician.
. Subject has positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV), or treponema pallidum antibody.
. Subjects who have undergone major surgery within 3 months before screening, or those who have received surgery that may significantly affect the pharmacokinetics or safety evaluation of the study drug, are judged by the investigators to be unsuitable for participation.
. Participated in other clinical trials within 3 months before screening or plan to participate in other clinical trials during this study.
. Blood loss or blood donation of more than 200 mL within 3 months before screening, or intended to donate blood during or within 1 month after the end of the trial.
. Those who have been vaccinated with inactivated/live/attenuated vaccines within 1 month before screening or who have an intention to vaccinate during the trial.
. History of kidney transplantation surgery.
. Patients with mild, moderate, or severe renal impairment are expected to receive any type of dialysis during the study (cohort B-D); Those who need treatment other than intermittent hemodialysis therapy during the study period, or those who have not been able to maintain a stable hemodialysis of 2 to 4 times per week for at least 1 month before administration (Group E).