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Not yet recruitingNCT06039254Updated Sep 15, 2023

Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function

A Phase 1 interventional study of HRS-1780 in Chronic Kidney Disease, sponsored by Shandong Suncadia Medicine Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by Shandong Suncadia Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Nov 2023, 2 years 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 1
Study type
Interventional
Enrollment
27
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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 disease.

02

Conditions studied

03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's planned enrollment of 27 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Shandong Suncadia Medicine Co., Ltd. is the lead sponsor of 86 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy subjects:
  1. 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.;
  2. Male and female, 18 to 70 years of age, inclusive;
  3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
  4. Normal glomerular filtration rate;
  5. No clinically significant abnormalities in physical examination, vital signs, laboratory tests, 12-lead ECG, etc. at the investigator's discretion;
  6. 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:

  1. 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.;
  2. Male and female, 18 to 70 years of age, inclusive;
  3. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive;
  4. Glomerular filtration rate between 30 to 89 mL/min, inclusive;
  5. 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;
  6. 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.

Exclusion criteria

Exclusion Criteria:

  • Healthy subjects:
  1. 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;
  2. Clinically significant abnormalities in 12-Lead ECG;
  3. 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;
  4. 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;
  5. Use of any prescription medicine, over-the-counter medicine, herbal remedy, or nutritional supplement within 2 weeks prior to screening;
  6. 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;
  7. 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;
  8. 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;
  9. Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
  10. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
  11. 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;
  12. Inability to tolerate venipuncture blood collection;
  13. 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:

  1. History of kidney transplant or plan to receive a kidney transplant during the trial;
  2. 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;
  3. Clinically significant abnormalities in 12-Lead ECG;
  4. 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;
  5. 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;
  6. 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;
  7. 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;
  8. 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;
  9. 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;
  10. Unwilling or unable to comply with the contraceptive methods detailed in this protocol;
  11. Positive hepatitis B virus, hepatitis B core antibody, hepatitis C virus, human immunodeficiency virus, or syphilis at screening;
  12. 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;
  13. Inability to tolerate venipuncture blood collection;
  14. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
27 participants (estimated)

Study arms

  • Experimental
    Healthy subjects group

    Drug: HRS-1780

  • Experimental
    Mild renal impairment group

    Drug: HRS-1780

  • Experimental
    Moderate renal impairment group

    Drug: HRS-1780

Interventions

  • DrugHRS-1780

    Single dose in each arm

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics-Cmax

    Maximum observed concentration of HRS-1780

    Time frame: Start of Treatment to end of study (approximately 1 week)

  2. Pharmacokinetics-AUC0-last

    Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration

    Time frame: Start of Treatment to end of study (approximately 1 week)

  3. Pharmacokinetics-AUC0-inf

    Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration

    Time frame: Start of Treatment to end of study (approximately 1 week)

Secondary outcomes

  1. Pharmacokinetics-Tmax

    Time to Cmax of HRS-1780

    Time frame: Start of Treatment to end of study (approximately 1 week)

  2. Pharmacokinetics-t1/2

    Terminal elimination half-life of HRS-1780

    Time frame: Start of Treatment to end of study (approximately 1 week)

  3. Pharmacokinetics-CL/F

    Apparent clearance of HRS-1780

    Time frame: Start of Treatment to end of study (approximately 1 week)

  4. Pharmacokinetics-Vz/F

    Apparent volume of distribution during terminal phase of HRS-1780

    Time frame: Start of Treatment to end of study (approximately 1 week)

  5. Pharmacokinetics-Cumulative excretion (Ae)

    Cumulative amount of HRS-1780 excreted in urine

    Time frame: Start of Treatment to end of study (approximately 1 week)

  6. Pharmacokinetics-Cumulative excretion rate (Ae%)

    Cumulative percentage of HRS-1780 recovered in urine

    Time frame: Start of Treatment to end of study (approximately 1 week)

  7. Pharmacokinetics-Renal clearance (CLr)

    Clearance of HRS-1780 by kidney

    Time frame: Start of Treatment to end of study (approximately 1 week)

  8. Binding rates of plasma protein (BRPP) of HRS-1780

    Binding rates of plasma protein

    Time frame: Start of Treatment to end of study (approximately 1 week)

  9. Adverse events

    Incidence and severity of adverse events

    Time frame: Start of Treatment to end of study (approximately 1 week)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06039254
Lead sponsor
Shandong Suncadia Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Sep 15, 2023
Start date
Sep 2023 (estimated)
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 8, 2023 (estimated)
Last update
Sep 15, 2023

Study contacts

Yue Fei
Contact
yue.fei@hengrui.com
0518-82342973

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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