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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05638126
• Other study ID #: HRS-1780-101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: February 2, 2023
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Shandong Suncadia Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 96
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. 18-45 years old (including boundary value, whichever is at the time of signing the informed consent form), healthy male.

2. Weight =50 kg, body mass index (BMI = body mass/height square (kg/m2)) is in the range of 18-28 (including boundary values)

3. 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.

4. 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:

1. People with a history of hypertension.

2. People with severe systemic infectious diseases, serious trauma or major surgical surgery before screening; those who plan to undergo surgery during the trial

3. There has been a history of clinical abnormal gastric emptying and severe chronic gastrointestinal diseases.

4. Diseases found to show clinical significance before screening

5. Combined with diuretics before screening

6. Drugs were used 2 weeks before screening.

7. Laboratory or physical examination with any abnormalities and the researcher's judgment is clinically significant.

8. 12-lead electrocardiogram is abnormal and of clinical significance

9. Positive for hepatitis B surface antigen, positive for hepatitis C antibody, positive for syphilis spirochete antibody, positive for HIV antibody

10. 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)

11. 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)

12. 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.

13. Smoking more than 5 cigarettes a day in the 3 months before screening or using any tobacco products 48 h before administration.

14. Drink/eat coffee, tea, grapefruit, chocolate or soft drinks, such as cola containing methamphetrine (tein, caffeine or cocoaine) within 3 days before screening

15. 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

16. 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

17. Inability tolerate venous puncture and blood collection or dizziness

18. Subjects who believe that there are other factors that are not suitable to participate in this test

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• HRS-1780 table or placebo
HRS-1780 table or placebo single dose
• HRS-1780 table or placebo
HRS-1780 table or placebo single dose with food effect
• HRS-1780 table or placebo
HRS-1780 table or placebo multiple dose

Locations

Country	Name	City	State
China	West China Hospital of Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Suncadia Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-1780 tablets		About a month from the first medication to the evaluation.
Secondary	Assess the concentration of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluation of AUC0-t of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluation of AUC0-8 of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluation of Tmax of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluation of Cmax of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluation of t1/2 of HRS-1780 in plasma and urine		About 4 weeks after the first dose
Secondary	Evaluate the blood pressure of subjects over time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the heart rate of subjects over time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the concentrations of plasma renin activity of subjects over time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the plasma aldosterone of subjects over time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the plasma angiotensin II of subjects over time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the urinary creatinine curve of subjects with time after HRS-1780 administration		About 4 weeks after the first dose
Secondary	Evaluate the change curve of urine creatinine over time relative to baseline in subjects after HRS-1780 administration		About 4 weeks after the first dose