Chronic Kidney DiseasePhase 1NCT06039254
Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
A Phase 1 study testing HRS-1780 in people with Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd..
Trial summary
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- HRS-1780
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to 8 Dec 2023
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subjects：
- Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
- Male and female, 18 to 70 years of age, inclusive;
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
- Normal glomerular filtration rate;
- No clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
Show all 14Show fewer
- Men and WOCBP must agree to take highly effective contraceptive methods detailed in the protocol, have no plan to have a child from signing the consent form until at least one month after IP administration, and must not undertake for sperm/egg donation. Female participants should not be lactating.
- Renal impairment subjects：
- Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
- Male and female, 18 to 70 years of age, inclusive;
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
- Glomerular filtration rate between 30 to 89 mL/min, inclusive;
- Except for renal impairment and related complications, no clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
- Men and WOCBP must agree to take highly effective contraceptive methods detailed in the protocol, have no plan to have a child from signing the consent form until at least one month after IP administration, and must not undertake for sperm/egg donation. Female participants should not be lactating.
Who cannot join
- Healthy subjects：
- Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
- Clinically significant abnormalities in 12-Lead ECG;
- Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
- Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
- Use of any prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
Show all 29Show fewer
- Consumption of more than 14 units of alcohol per week within 6 months prior to screening, or incapable to refrain from consuming alcohol during the study, or positive alcohol breath test result;
- Consumption of more than 5 cigarettes daily (or products with an equivalent amount of nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours prior to dosing;
- History of illicit or prescription drug abuse or addiction in the past 5 years, or illicit or prescription drug abuse within 3 months prior to screening, or positive urine drug screen;
- Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
- Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
- History or evidence of clinically significant disorders and deemed not suitable to participate in the study by the investigator within 6 months prior to screening;
- Inability to tolerate venipuncture blood collection;
- Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study.
- Renal impairment subjects：
- History of kidney transplant or plan to receive a kidney transplant during the trial;
- Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
- Clinically significant abnormalities in 12-Lead ECG;
- Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
- Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
- Except for treatment of renal impairment and related complications, use of other prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
- Consumption of more than 14 units of alcohol per week within 6 months prior to screening, or incapable to refrain from consuming alcohol during the study, or positive alcohol breath test result;
- Consumption of more than 5 cigarettes daily (or products with an equivalent amount of nicotine) within 3 months prior to screening, or use of any tobacco products 48 hours prior to dosing;
- History of illicit or prescription drug abuse or addiction in the past 5 years, or illicit or prescription drug abuse within 3 months prior to screening, or positive urine drug screen;
- Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
- Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
- History or evidence of clinically significant disorders and deemed not suitable to participate in the study by the investigator within 6 months prior to screening;
- Inability to tolerate venipuncture blood collection;
- Any other circumstances that, in the investigator's judgment, may increase the risk to the subject, or associated with the subject's participation in and completion of the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
This is a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- HRS-1780
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1780Drug
Single dose in each arm
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects group | Experimental | Not described Receives: Drug: HRS-1780 |
| Mild renal impairment group | Experimental | Not described Receives: Drug: HRS-1780 |
| Moderate renal impairment group | Experimental | Not described Receives: Drug: HRS-1780 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics-Cmax
Maximum observed concentration of HRS-1780
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration
Measured: Start of Treatment to end of study (approximately 1 week)
Secondary outcomes (9)
Pharmacokinetics-Tmax
Time to Cmax of HRS-1780
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-t1/2
Terminal elimination half-life of HRS-1780
Measured: Start of Treatment to end of study (approximately 1 week）
Pharmacokinetics-CL/F
Apparent clearance of HRS-1780
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of HRS-1780
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion (Ae)
Cumulative amount of HRS-1780 excreted in urine
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion rate (Ae%)
Cumulative percentage of HRS-1780 recovered in urine
Measured: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Renal clearance (CLr)
Clearance of HRS-1780 by kidney
Measured: Start of Treatment to end of study (approximately 1 week)
Binding rates of plasma protein (BRPP) of HRS-1780
Binding rates of plasma protein
Measured: Start of Treatment to end of study (approximately 1 week)
Adverse events
Incidence and severity of adverse events
Measured: Start of Treatment to end of study (approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study startSep 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion8 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Shandong Suncadia Medicine Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039254
- Sponsor's protocol ID
- HRS-1780-102
- Status last verified
- Aug 2023
- First submitted
- 7 Aug 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Non-randomized, Open-label, Parallel-controlled Study to Evaluate the Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT06039254
- Acronym / sponsor ID
- HRS-1780-102
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Shandong Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 8 Dec 2023 (estimated)
- First posted
- 15 Sep 2023 (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 a multicenter, non-randomized, open-label, parallel-controlled study. The main objective is to evaluate the safety and pharmacokinetics of HRS-1780 in subjects with mild and moderate renal impairment versus healthy subjects, and to provide a basis for dose selection of HRS-1780 in patients with chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects group | Experimental | Drug: HRS-1780 |
| Mild renal impairment group | Experimental | Drug: HRS-1780 |
| Moderate renal impairment group | Experimental | Drug: HRS-1780 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy subjects：
- Able to understand the trial procedures and possible risks, volunteers to participate in the trial, willing and able to comply with all scheduled visits and study procedures, and provides written informed consent.;
- Male and female, 18 to 70 years of age, inclusive;
- Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
- Normal glomerular filtration rate;
Key exclusion criteria (29 listed)
- Healthy subjects：
- Known history or suspected of being allergic to study drug or any component of it, or significant allergic reactions to other biologic products and drugs, or severe food allergies;
- Clinically significant abnormalities in 12-Lead ECG;
- Severe infections, injuries, or major surgeries as determined by the investigator within 3 months prior to screening, or plans to have surgeries during the study;
- Receipt of medical devices or another investigational drug (including placebo) within 3 months or 5 half-lives, whichever is longer prior to screening, or plans to participate in another clinical study during this study;
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-1780Single dose in each arm | Drug | Healthy subjects group, Mild renal impairment group, Moderate renal impairment group |
Primary outcome
Pharmacokinetics-Cmax
Time frame: Start of Treatment to end of study (approximately 1 week)
Maximum observed concentration of HRS-1780
Pharmacokinetics-AUC0-last
Time frame: Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
Pharmacokinetics-AUC0-inf
Time frame: Start of Treatment to end of study (approximately 1 week)
Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration
9 secondary outcomes
Pharmacokinetics-Tmax
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-t1/2
Time frame: Start of Treatment to end of study (approximately 1 week）
Pharmacokinetics-CL/F
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Vz/F
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion (Ae)
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Cumulative excretion rate (Ae%)
Time frame: Start of Treatment to end of study (approximately 1 week)
Pharmacokinetics-Renal clearance (CLr)
Time frame: Start of Treatment to end of study (approximately 1 week)
Binding rates of plasma protein (BRPP) of HRS-1780
Time frame: Start of Treatment to end of study (approximately 1 week)
Adverse events
Time frame: Start of Treatment to end of study (approximately 1 week)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1780 in people with Chronic Kidney Disease, run by Shandong Suncadia Medicine Co., Ltd..
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 14 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yue Fei (0518-82342973, yue.fei@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics-Cmax (time frame: Start of Treatment to end of study (approximately 1 week)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2023.