Contrast-Enhanced Magnetic Resonance Imaging DetectionPhase 1NCT06657560
Pharmacokinetics, Dialysability and Safety of HRS-9231 in Healthy Volunteers and in Patients With Impaired Renal Function
A Phase 1 study testing HRS-9231 in people with Contrast-Enhanced Magnetic Resonance Imaging Detection, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Contrast-Enhanced Magnetic Resonance Imaging Detection
- What is being tested?
- HRS-9231
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2024to 3 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Cohort A - normal renal function: ≥ 90 mL/min and < 130 mL/min; Cohort B - mild renal impairment: 60 < 90 mL/min; Cohort C - moderate renal impairment: 30 < 60 mL/min; Cohort D - severe renal impairment: 15 < 30 mL/min; Cohort E - ESRD subjects requiring HD: < 15 mL/min.
- 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.
Who cannot join
- 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.
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- 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).
- Incontinence or anuria (e.g., <100 mL/d) in patients with mild, moderate, and severe renal impairment (B-D group).
Trial locations and contacts
1 site in 1 country.
China1 site
Shandong First Medical University First Affiliated Hospital (Shandong Qianfoshan Hospital)
Jinan, Shandong, 250014
About this study
Official title: Pharmacokinetics (PK) Study of HRS-9231 Injection in Chinese Subjects With Renal Impairment and Normal Renal Function
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.
- Being tested
- HRS-9231
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9231Drug
HRS-9231
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Healthy volunteer with stable normal renal function defined with an absolute value of eGFR ≥ 90 and < 130 mL/min based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 25% between the 2 measurements. Receives: Drug: HRS-9231 |
| Cohort B | Experimental | Patient with stable mild renal impairment defined with an absolute value of eGFR ≥ 60 and <90 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 25% between the 2 measurements. Receives: Drug: HRS-9231 |
| Cohort C | Experimental | Patient with stable moderate renal impairment defined with an absolute value of eGFR between ≥ 30 and <60 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements. Receives: Drug: HRS-9231 |
| Cohort D | Experimental | Patient with stable severe renal impairment defined with an absolute value of eGFR between ≥ 15 and <30 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements. Receives: Drug: HRS-9231 |
| Cohort E | Experimental | Patient with end-stage renal failure who requires 3 hemodialysis sessions per week and defined with an absolute value of eGFR <15 mL/min. Receives: Drug: HRS-9231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Observed maximum plasma concentration. Blood samples will be collected.
Measured: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
AUC0-t
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Measured: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Measured: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Tmax
Observed time to reach C(max). Blood samples will be collected.
Measured: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Ae
Amount excreted. Urine samples will be collected.
Measured: Prior to HRS-9231 administration and Day 5 (for all cohorts) or within 6 days (only for cohort D) after administration.
Secondary outcomes (1)
Incidence of treatment emergent AEs (TEAEs)
Measured: From screening visit to 6 months after administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start14 Oct 2024
- Primary completion3 Jul 2025
- Study completion3 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Contrast-Enhanced Magnetic Resonance Imaging DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657560
- Sponsor's protocol ID
- HRS-9231-103
- Status last verified
- Mar 2025
- First submitted
- 23 Oct 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han Q, Zhang R, He Y, Yan R, Shi L, Wu N, Yu L, Muhetaer G, Meng X, Liu L, Yin T, Huang Y, Zhao W. Pharmacokinetics, Elimination and Dialyzability of HRS-9231 in Patients with Varying Degrees of Renal Impairment. Clin Pharmacokinet. 2026 Aug 22. doi: 10.1007/s40262-026-01688-4. Online ahead of print.
PubMed 42631820
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics (PK) Study of HRS-9231 Injection in Chinese Subjects With Renal Impairment and Normal Renal Function
- ClinicalTrials.gov ID
- NCT06657560
- Acronym / sponsor ID
- HRS-9231-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Shanghai Shengdi Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 3 Jul 2025 (actual)
- Study completion
- 3 Jul 2025 (actual)
- First posted
- 24 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: HRS-9231Healthy volunteer with stable normal renal function defined with an absolute value of eGFR ≥ 90 and < 130 mL/min based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 25% between the 2 measurements. |
| Cohort B | Experimental | Drug: HRS-9231Patient with stable mild renal impairment defined with an absolute value of eGFR ≥ 60 and <90 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 25% between the 2 measurements. |
| Cohort C | Experimental | Drug: HRS-9231Patient with stable moderate renal impairment defined with an absolute value of eGFR between ≥ 30 and <60 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements. |
| Cohort D | Experimental | Drug: HRS-9231Patient with stable severe renal impairment defined with an absolute value of eGFR between ≥ 15 and <30 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements. |
| Cohort E | Experimental | Drug: HRS-9231Patient with end-stage renal failure who requires 3 hemodialysis sessions per week and defined with an absolute value of eGFR <15 mL/min. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- Cohort A - normal renal function: ≥ 90 mL/min and < 130 mL/min; Cohort B - mild renal impairment: 60 < 90 mL/min; Cohort C - moderate renal impairment: 30 < 60 mL/min; Cohort D - severe renal impairment: 15 < 30 mL/min; Cohort E - ESRD subjects requiring HD: < 15 mL/min.
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9231HRS-9231 | Drug | Cohort A, Cohort B, Cohort C, Cohort D, Cohort E |
Primary outcome
Cmax
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Observed maximum plasma concentration. Blood samples will be collected.
AUC0-t
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
AUC0-∞
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Tmax
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Observed time to reach C(max). Blood samples will be collected.
Ae
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or within 6 days (only for cohort D) after administration.
Amount excreted. Urine samples will be collected.
1 secondary outcome
Incidence of treatment emergent AEs (TEAEs)
Time frame: From screening visit to 6 months after administration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 42631820Han Q, Zhang R, He Y, Yan R, Shi L, Wu N, Yu L, Muhetaer G, Meng X, Liu L, Yin T, Huang Y, Zhao W. Pharmacokinetics, Elimination and Dialyzability of HRS-9231 in Patients with Varying Degrees of Renal Impairment. Clin Pharmacokinet. 2026 Aug 22. doi: 10.1007/s40262-026-01688-4. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-9231 in people with Contrast-Enhanced Magnetic Resonance Imaging Detection, run by Shanghai Shengdi Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cmax (time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06657560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.