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A Trial of HRS-7450 in Chinese Healthy Volunteers

Primary Purpose

Cerebral Stroke

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
HRS-7450 ;Placebo
Sponsored by
Fujian Shengdi Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy male and female subjects between 18 and 45 years of age (inclusive) at the screening visit Female weighed ≥ 45 kg, male weighed ≥ 50 kg, and all weighed ≤ was 90 kg, and a BMI between 18-28 kg/m²(inclusive) Subjects with fertility promised to have no fertility, sperm or egg donation plan and voluntarily take efficient contraceptive measures ( including partners ) within two weeks before screening and 6 months after the last administration Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial Exclusion Criteria: Subjects with a history of drug allergy, or a history of allergy ( asthma, urticaria, eczema, etc. ), or allergic constitution ( such as allergies to two or more drugs, food, and pollen ) or intolerance to any ingredients of the study drug Subjects with heart, respiration, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, nervous system disease or mental illness, metabolic dysfunction prior to screening or administration The results of physical examination, vital sign examination, laboratory examination, etc. during the screening are deemed clinically significant Subjects with risk factors for torsades de pointes ventricular tachycardia, or had a family history of short QT syndrome, long QT syndrome, unexplained sudden death in youth ( ≤ 40 years old ), drowning or sudden infant death syndrome in first-degree relatives ( i.e., biological parents, siblings or children ) Subjects with hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia are deemed clinically significant ECG examination is clinical significant, such as QTcF > 470ms Subjects with gastrointestinal, urinary and other bleeding tendencies or other high-risk bleeding tendencies within 3 weeks before screening; or those who have arterial puncture within the past 1 week that does not easily compress the hemostatic site were included ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin exceeded the upper limit of normal value during screening visit Positive test for human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or syphilis at the Screening Visit. Subjects who underwent surgery within 3 months before screening or schedule to have surgery during the trial, or those who have previously had surgery that may affect the PK profile or safety evaluation significantly of the study drug Subjects who received any IMP within 3 months before the screening visit or planned to participate in other clinical trials during the trial Received any drug that inhibits or induces liver metabolism of the drug within 1 month prior to screening visit Received any prescription drugs (including vaccines) or non-prescription medications, and herbal supplements within 2 weeks prior to screening visit Blood donation or blood loss≥200 mL within 3 month before screening, or schedule to donate blood during the trial or within 1 month after the end of the trial. Had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day of 200 ml each) in the 2 weeks prior to screening visit History of alcohol abuse [more than 14 units of alcohol intake in one week (1 unit of alcohol equivalent to 285 mL of beer, 25 mL of spirits, or 100ml of wine), more than twice a week] More than 10 cigarettes( or equivalent tobacco)per day in the 3 months prior to screening or unable to quit smoking during the trial period Positive urine drug test at the Screening Visit History of drug abuse within the past 5 years Pregnant or lactating women, or pregnancy test positive Can not tolerate venipuncture or have a history of needle sickness and blood Subjects with history of phlebitis In the opinion of the Investigator, subjects should be excluded in this trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohor 1: HRS-7450 dose 1 or Placebo;

    Cohor 1: HRS-7450 dose 2 or Placebo;

    Cohor 1: HRS-7450 dose 3 or Placebo;

    Cohor 1: HRS-7450 dose 4 or Placebo;

    Cohor 1: HRS-7450 dose 5 or Placebo;

    Arm Description

    Outcomes

    Primary Outcome Measures

    Adverse Events (AEs)
    Physical examination
    Incidence of clinically significant physical examination findings
    Vital signs
    Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
    12-lead electrocardiogram (ECG)
    Incidence of clinically significant findings in heart rate, PR interval, RR and QRS interval

    Secondary Outcome Measures

    Full Information

    First Posted
    October 9, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Fujian Shengdi Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06087094
    Brief Title
    A Trial of HRS-7450 in Chinese Healthy Volunteers
    Official Title
    Randomized, Double-blind, Placebo-controlled, Single-dose Ascending Study for the Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7450 in Healthy Subjects.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2023 (Anticipated)
    Study Completion Date
    December 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fujian Shengdi Pharmaceutical 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
    The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending doses of HRS-7450 given to healthy subjects, compared to placebo..

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Stroke

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohor 1: HRS-7450 dose 1 or Placebo;
    Arm Type
    Experimental
    Arm Title
    Cohor 1: HRS-7450 dose 2 or Placebo;
    Arm Type
    Experimental
    Arm Title
    Cohor 1: HRS-7450 dose 3 or Placebo;
    Arm Type
    Experimental
    Arm Title
    Cohor 1: HRS-7450 dose 4 or Placebo;
    Arm Type
    Experimental
    Arm Title
    Cohor 1: HRS-7450 dose 5 or Placebo;
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    HRS-7450 ;Placebo
    Intervention Description
    HRS-7450 or Placebo
    Primary Outcome Measure Information:
    Title
    Adverse Events (AEs)
    Time Frame
    8 +/- 1 days
    Title
    Physical examination
    Description
    Incidence of clinically significant physical examination findings
    Time Frame
    2 days
    Title
    Vital signs
    Description
    Incidence of clinically significant findings in systolic and diastolic blood pressure, heart rate and body temperature
    Time Frame
    2 days
    Title
    12-lead electrocardiogram (ECG)
    Description
    Incidence of clinically significant findings in heart rate, PR interval, RR and QRS interval
    Time Frame
    24 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy male and female subjects between 18 and 45 years of age (inclusive) at the screening visit Female weighed ≥ 45 kg, male weighed ≥ 50 kg, and all weighed ≤ was 90 kg, and a BMI between 18-28 kg/m²(inclusive) Subjects with fertility promised to have no fertility, sperm or egg donation plan and voluntarily take efficient contraceptive measures ( including partners ) within two weeks before screening and 6 months after the last administration Able to provide written, informed consent prior to initiation of any trial-related procedures, and able, in the opinion of the Principal Investigator, to comply with all the requirements of the trial Exclusion Criteria: Subjects with a history of drug allergy, or a history of allergy ( asthma, urticaria, eczema, etc. ), or allergic constitution ( such as allergies to two or more drugs, food, and pollen ) or intolerance to any ingredients of the study drug Subjects with heart, respiration, endocrine, metabolism, kidney, liver, gastrointestinal tract, skin, infection, malignant tumor, blood, nervous system disease or mental illness, metabolic dysfunction prior to screening or administration The results of physical examination, vital sign examination, laboratory examination, etc. during the screening are deemed clinically significant Subjects with risk factors for torsades de pointes ventricular tachycardia, or had a family history of short QT syndrome, long QT syndrome, unexplained sudden death in youth ( ≤ 40 years old ), drowning or sudden infant death syndrome in first-degree relatives ( i.e., biological parents, siblings or children ) Subjects with hyperkalemia, hypokalemia, hypermagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia are deemed clinically significant ECG examination is clinical significant, such as QTcF > 470ms Subjects with gastrointestinal, urinary and other bleeding tendencies or other high-risk bleeding tendencies within 3 weeks before screening; or those who have arterial puncture within the past 1 week that does not easily compress the hemostatic site were included ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin exceeded the upper limit of normal value during screening visit Positive test for human immunodeficiency virus (HIV-1 and HIV-2), hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV) or syphilis at the Screening Visit. Subjects who underwent surgery within 3 months before screening or schedule to have surgery during the trial, or those who have previously had surgery that may affect the PK profile or safety evaluation significantly of the study drug Subjects who received any IMP within 3 months before the screening visit or planned to participate in other clinical trials during the trial Received any drug that inhibits or induces liver metabolism of the drug within 1 month prior to screening visit Received any prescription drugs (including vaccines) or non-prescription medications, and herbal supplements within 2 weeks prior to screening visit Blood donation or blood loss≥200 mL within 3 month before screening, or schedule to donate blood during the trial or within 1 month after the end of the trial. Had taken a special diet (including dragon fruit, mango, grapefruit, and/or xanthine diet, chocolate) and/or consumed excessive amounts of tea, coffee, grapefruit/grapefruit juice, and/or caffeinated beverages (averaging more than 8 cups per day of 200 ml each) in the 2 weeks prior to screening visit History of alcohol abuse [more than 14 units of alcohol intake in one week (1 unit of alcohol equivalent to 285 mL of beer, 25 mL of spirits, or 100ml of wine), more than twice a week] More than 10 cigarettes( or equivalent tobacco)per day in the 3 months prior to screening or unable to quit smoking during the trial period Positive urine drug test at the Screening Visit History of drug abuse within the past 5 years Pregnant or lactating women, or pregnancy test positive Can not tolerate venipuncture or have a history of needle sickness and blood Subjects with history of phlebitis In the opinion of the Investigator, subjects should be excluded in this trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yuanyuan Huang
    Phone
    +0518-82342973
    Email
    yuanyuan.huang@hengrui.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    A Trial of HRS-7450 in Chinese Healthy Volunteers

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