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

Primary Purpose

Chronic Kidney Disease

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HRS-1780
Sponsored by
Shandong Suncadia Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - 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; 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. Exclusion Criteria: - 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; 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Healthy subjects group

    Mild renal impairment group

    Moderate renal impairment group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics-Cmax
    Maximum observed concentration of HRS-1780
    Pharmacokinetics-AUC0-last
    Area under the concentration-time curve from time 0 to last time point after HRS-1780 administration
    Pharmacokinetics-AUC0-inf
    Area under the concentration-time curve from time 0 to infinity after HRS-1780 administration

    Secondary Outcome Measures

    Pharmacokinetics-Tmax
    Time to Cmax of HRS-1780
    Pharmacokinetics-t1/2
    Terminal elimination half-life of HRS-1780
    Pharmacokinetics-CL/F
    Apparent clearance of HRS-1780
    Pharmacokinetics-Vz/F
    Apparent volume of distribution during terminal phase of HRS-1780
    Pharmacokinetics-Cumulative excretion (Ae)
    Cumulative amount of HRS-1780 excreted in urine
    Pharmacokinetics-Cumulative excretion rate (Ae%)
    Cumulative percentage of HRS-1780 recovered in urine
    Pharmacokinetics-Renal clearance (CLr)
    Clearance of HRS-1780 by kidney
    Binding rates of plasma protein (BRPP) of HRS-1780
    Binding rates of plasma protein
    Adverse events
    Incidence and severity of adverse events

    Full Information

    First Posted
    August 7, 2023
    Last Updated
    September 14, 2023
    Sponsor
    Shandong Suncadia Medicine Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06039254
    Brief Title
    Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    November 30, 2023 (Anticipated)
    Study Completion Date
    December 8, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shandong Suncadia Medicine Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    27 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Healthy subjects group
    Arm Type
    Experimental
    Arm Title
    Mild renal impairment group
    Arm Type
    Experimental
    Arm Title
    Moderate renal impairment group
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-1780
    Intervention Description
    Single dose in each arm
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics-Cmax
    Description
    Maximum observed concentration of HRS-1780
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-AUC0-last
    Description
    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)
    Title
    Pharmacokinetics-AUC0-inf
    Description
    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 Outcome Measure Information:
    Title
    Pharmacokinetics-Tmax
    Description
    Time to Cmax of HRS-1780
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-t1/2
    Description
    Terminal elimination half-life of HRS-1780
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-CL/F
    Description
    Apparent clearance of HRS-1780
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-Vz/F
    Description
    Apparent volume of distribution during terminal phase of HRS-1780
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-Cumulative excretion (Ae)
    Description
    Cumulative amount of HRS-1780 excreted in urine
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-Cumulative excretion rate (Ae%)
    Description
    Cumulative percentage of HRS-1780 recovered in urine
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Pharmacokinetics-Renal clearance (CLr)
    Description
    Clearance of HRS-1780 by kidney
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Binding rates of plasma protein (BRPP) of HRS-1780
    Description
    Binding rates of plasma protein
    Time Frame
    Start of Treatment to end of study (approximately 1 week)
    Title
    Adverse events
    Description
    Incidence and severity of adverse events
    Time Frame
    Start of Treatment to end of study (approximately 1 week)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: - 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; 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. Exclusion Criteria: - 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; 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yue Fei
    Phone
    0518-82342973
    Email
    yue.fei@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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