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Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

Primary Purpose

Chronic Kidney Disease

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
HRS-1780 table or placebo
HRS-1780 table or placebo
HRS-1780 table or placebo
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 - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: 18-45 years old (including boundary value, whichever is at the time of signing the informed consent form), healthy male. Weight ≥50 kg, body mass index (BMI = body mass/height square (kg/m2)) is in the range of 18-28 (including boundary values) Obtain informed consent before any activity related to the experiment begins, have a full understanding of the purpose and significance of the experiment, and be willing to comply with the test plan and dietary requirements. Subjects (including partners) have no family planning within 3 months from the beginning of the signing of the informed consent form to the last dose, and are willing to adopt the efficient contraceptive measures stipulated in the program and guarantee not to donate sperm. Exclusion Criteria: People with a history of hypertension. People with severe systemic infectious diseases, serious trauma or major surgical surgery before screening; those who plan to undergo surgery during the trial There has been a history of clinical abnormal gastric emptying and severe chronic gastrointestinal diseases. Diseases found to show clinical significance before screening Combined with diuretics before screening Drugs were used 2 weeks before screening. Laboratory or physical examination with any abnormalities and the researcher's judgment is clinically significant. 12-lead electrocardiogram is abnormal and of clinical significance Positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for syphilis spirochete antibody, positive for HIV antibody People with severe allergic diseases or known or suspected of being allergic to any of the ingredients in the research drug, allergic constitution (multiple drugs and food allergies) Participated in the clinical trial of any drug or medical device within the first 3 months of screening or planned to participate in the clinical trial of other drugs or medical devices during the trial period (subject to the signing of informed consent) Drink more than 14 units of alcohol per week in the first 6 months of screening; or those who have taken alcohol products 48 hours before administration; or those who have tested positive for alcohol exhalation during the baseline period. Smoking more than 5 cigarettes a day in the 3 months before screening or using any tobacco products 48 h before administration. Drink/eat coffee, tea, grapefruit, chocolate or soft drinks, such as cola containing methamphetrine (tein, caffeine or cocoaine) within 3 days before screening Those who have had a history of drug abuse in the past five years or have used drugs in the first three months of the trial; or urine drugs are screened positive Blood donation ≥ 200 mL within 1 month before screening; or blood donation ≥ 400 mL within 3 months before screening; or trauma or surgical surgery with blood donation (plasma or platelets) or blood loss of ≥ 400 mL within 2 weeks Inability tolerate venous puncture and blood collection or dizziness Subjects who believe that there are other factors that are not suitable to participate in this test

Sites / Locations

  • West China Hospital of Sichuan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Part 1

Part 2

Part 3

Arm Description

HRS-1780 table or placebo single dose

HRS-1780 table or placebo single dose with food effect

HRS-1780 table or placebo multiple dose

Outcomes

Primary Outcome Measures

Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets

Secondary Outcome Measures

Assess the concentration of HRS-1780 in plasma and urine
Evaluation of AUC0-t of HRS-1780 in plasma and urine
Evaluation of AUC0-∞ of HRS-1780 in plasma and urine
Evaluation of Tmax of HRS-1780 in plasma and urine
Evaluation of Cmax of HRS-1780 in plasma and urine
Evaluation of t1/2 of HRS-1780 in plasma and urine
Evaluate the blood pressure of subjects over time after HRS-1780 administration
Evaluate the heart rate of subjects over time after HRS-1780 administration
Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration
Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration
Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration
Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration
Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration

Full Information

First Posted
November 24, 2022
Last Updated
October 23, 2023
Sponsor
Shandong Suncadia Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05638126
Brief Title
Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects
Official Title
A Phase I Single and Multiple Ascending Dose and Food Effect Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-1780 Tablets in Healthy Male Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2023 (Actual)
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
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 randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-1780 in healthy subjects, and to evaluate the food effect on PK of HRS-1780.

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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part 1
Arm Type
Experimental
Arm Description
HRS-1780 table or placebo single dose
Arm Title
Part 2
Arm Type
Experimental
Arm Description
HRS-1780 table or placebo single dose with food effect
Arm Title
Part 3
Arm Type
Experimental
Arm Description
HRS-1780 table or placebo multiple dose
Intervention Type
Drug
Intervention Name(s)
HRS-1780 table or placebo
Intervention Description
HRS-1780 table or placebo single dose
Intervention Type
Drug
Intervention Name(s)
HRS-1780 table or placebo
Intervention Description
HRS-1780 table or placebo single dose with food effect
Intervention Type
Drug
Intervention Name(s)
HRS-1780 table or placebo
Intervention Description
HRS-1780 table or placebo multiple dose
Primary Outcome Measure Information:
Title
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets
Time Frame
About a month from the first medication to the evaluation.
Secondary Outcome Measure Information:
Title
Assess the concentration of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluation of AUC0-t of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluation of AUC0-∞ of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluation of Tmax of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluation of Cmax of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluation of t1/2 of HRS-1780 in plasma and urine
Time Frame
About 4 weeks after the first dose
Title
Evaluate the blood pressure of subjects over time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the heart rate of subjects over time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration
Time Frame
About 4 weeks after the first dose
Title
Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration
Time Frame
About 4 weeks after the first dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-45 years old (including boundary value, whichever is at the time of signing the informed consent form), healthy male. Weight ≥50 kg, body mass index (BMI = body mass/height square (kg/m2)) is in the range of 18-28 (including boundary values) Obtain informed consent before any activity related to the experiment begins, have a full understanding of the purpose and significance of the experiment, and be willing to comply with the test plan and dietary requirements. Subjects (including partners) have no family planning within 3 months from the beginning of the signing of the informed consent form to the last dose, and are willing to adopt the efficient contraceptive measures stipulated in the program and guarantee not to donate sperm. Exclusion Criteria: People with a history of hypertension. People with severe systemic infectious diseases, serious trauma or major surgical surgery before screening; those who plan to undergo surgery during the trial There has been a history of clinical abnormal gastric emptying and severe chronic gastrointestinal diseases. Diseases found to show clinical significance before screening Combined with diuretics before screening Drugs were used 2 weeks before screening. Laboratory or physical examination with any abnormalities and the researcher's judgment is clinically significant. 12-lead electrocardiogram is abnormal and of clinical significance Positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for syphilis spirochete antibody, positive for HIV antibody People with severe allergic diseases or known or suspected of being allergic to any of the ingredients in the research drug, allergic constitution (multiple drugs and food allergies) Participated in the clinical trial of any drug or medical device within the first 3 months of screening or planned to participate in the clinical trial of other drugs or medical devices during the trial period (subject to the signing of informed consent) Drink more than 14 units of alcohol per week in the first 6 months of screening; or those who have taken alcohol products 48 hours before administration; or those who have tested positive for alcohol exhalation during the baseline period. Smoking more than 5 cigarettes a day in the 3 months before screening or using any tobacco products 48 h before administration. Drink/eat coffee, tea, grapefruit, chocolate or soft drinks, such as cola containing methamphetrine (tein, caffeine or cocoaine) within 3 days before screening Those who have had a history of drug abuse in the past five years or have used drugs in the first three months of the trial; or urine drugs are screened positive Blood donation ≥ 200 mL within 1 month before screening; or blood donation ≥ 400 mL within 3 months before screening; or trauma or surgical surgery with blood donation (plasma or platelets) or blood loss of ≥ 400 mL within 2 weeks Inability tolerate venous puncture and blood collection or dizziness Subjects who believe that there are other factors that are not suitable to participate in this test
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610044
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects

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