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

NCT ID: NCT05638126

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-02
• Study Completion Date: 2023-12-31

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.

Conditions

Chronic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Part 1

HRS-1780 table or placebo single dose

Group Type: EXPERIMENTAL

HRS-1780 table or placebo

Intervention Type: DRUG

HRS-1780 table or placebo single dose

Part 2

HRS-1780 table or placebo single dose with food effect

Group Type: EXPERIMENTAL

HRS-1780 table or placebo

Intervention Type: DRUG

HRS-1780 table or placebo single dose with food effect

Part 3

HRS-1780 table or placebo multiple dose

Group Type: EXPERIMENTAL

HRS-1780 table or placebo

Intervention Type: DRUG

HRS-1780 table or placebo multiple dose

Interventions

HRS-1780 table or placebo

HRS-1780 table or placebo single dose

Intervention Type: DRUG

HRS-1780 table or placebo

HRS-1780 table or placebo single dose with food effect

Intervention Type: DRUG

HRS-1780 table or placebo

HRS-1780 table or placebo multiple dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shandong Suncadia Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Countries

China

References

Shen Q, Li L, Qian W, Dong X, Bao M, Huang R, Li N, Ye Z, Cheng G, Wang Q, Shen K, Luo Z. A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. Expert Opin Investig Drugs. 2024 Oct;33(10):1083-1093. doi: 10.1080/13543784.2024.2393867. Epub 2024 Aug 26.

Reference Type: DERIVED

PMID: 39155700 (View on PubMed)

Other Identifiers

HRS-1780-101

Identifier Type: -

Identifier Source: org_study_id