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

NCT05638126 | Unknown Phase 1

• 1 other identifier: HRS-1780-101
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• Assess the concentration of HRS-1780 in plasma and urine

  About 4 weeks after the first dose

• Evaluation of AUC0-t of HRS-1780 in plasma and urine

  About 4 weeks after the first dose

• Evaluation of AUC0-∞ of HRS-1780 in plasma and urine

  About 4 weeks after the first dose

• Evaluation of Tmax of HRS-1780 in plasma and urine

  About 4 weeks after the first dose

• Evaluation of Cmax of HRS-1780 in plasma and urine

  About 4 weeks after the first dose

Study Arms (3)

Part 1

EXPERIMENTAL

HRS-1780 table or placebo single dose

Drug: HRS-1780 table or placebo

Part 2

EXPERIMENTAL

HRS-1780 table or placebo single dose with food effect

Drug: HRS-1780 table or placebo

Part 3

EXPERIMENTAL

HRS-1780 table or placebo multiple dose

Drug: HRS-1780 table or placebo

Interventions

HRS-1780 table or placebo DRUG

HRS-1780 table or placebo single dose

Part 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

Related Publications (1)

• 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.

  PMID: 39155700 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 6, 2022
• Study Start: February 2, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 25, 2023

Record last verified: 2022-11

Locations

CN (1)