A Phase I Trial on the Relative Bioavailability and Food Effect of HRS-1893 Tablets in Healthy Subjects

NCT07272330 | Completed Phase 1

• 1 other identifier: HRS-1893-106
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase I clinical trial will investigate the relative bioavailability between two formulations of HRS-1893 tablets and the influence of food on the drug's pharmacokinetics in healthy adult participants. The safety and tolerability of HRS-1893 will also be monitored.

Conditions

Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• Peak concentration (Cmax)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• Area under the plasma concentration-time curve from time zero to the last quantifiable time point (AUC0-t)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC0-∞)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

Secondary Outcomes (5)

• Time to reach peak concentration (Tmax)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• Elimination half-life (t1/2)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• Apparent clearance (CL/F)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• Apparent volume of distribution (Vz/F)

  From Day 1 to Day 25 in part 1, from Day 1 to Day 17 in part 2.

• The incidence and severity of any adverse events (AEs)

  From Day 1 to Day 29 in part 1, from Day 1 to Day 21 in part 2.

Study Arms (2)

HRS-1893 tablet A and HRS-1893 tablet B Group

EXPERIMENTAL

Drug: HRS-1893 tablet A; Drug: HRS-1893 tablet B

HRS-1893 tablet B Group

EXPERIMENTAL

Drug: HRS-1893 tablet B

Interventions

HRS-1893 tablet A DRUG

Specified dose on specified days.

HRS-1893 tablet A and HRS-1893 tablet B Group

HRS-1893 tablet B DRUG

Specified dose on specified days.

HRS-1893 tablet A and HRS-1893 tablet B Group; HRS-1893 tablet B Group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18 to 55 years (inclusive), regardless of gender.
• Body mass index (BMI) between 19 and 28 kg/m² (inclusive), with body weight ≥50.0 kg and \<90.0 kg for men, and ≥45.0 kg and \<90.0 kg for women.
• No abnormalities of clinical significance are found upon comprehensive physical examination and laboratory tests, or only minor abnormalities that are deemed by the investigator not to affect the subject's eligibility for enrollment.
• No clinically significant abnormalities on the 12-lead ECG.
• The subject must understand the study procedures and methods, voluntarily agree to participate, and provide written informed consent.

You may not qualify if:

• Subjects with suspected hypersensitivity to the investigational drug or any excipient.
• The subject has a history of syncope.
• History of gastric or intestinal surgery that, in the investigator's judgment, may affect drug absorption.
• A positive result in any one of the following infectious disease screening tests during the screening period: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), treponema pallidum antibody (syphilis), or human immunodeficiency virus antibody/antigen (HIV-Ab/Ag).
• Subjects who meet any of the following criteria will be excluded: (1) Smoking: Average daily cigarette consumption of more than 5 cigarettes within the 4 weeks prior to screening. (2) Alcohol: Average daily alcohol intake exceeding 15 g within one week prior to screening (15 g of alcohol is equivalent to 450 mL of beer, 150 mL of wine, or 50 mL of low-alcohol spirits). (3) Non-compliance: Inability or unwillingness to abstain from smoking, alcohol, and caffeine-containing foods or beverages during the screening period and the entire study duration. (4) Diet: Have special dietary requirements, cannot comply with the standardized diet provided in the study, or have a history of substance abuse.
• History of substance abuse.
• Use of any prescription drugs, over-the-counter medications, or Chinese herbal medicines within 1 month prior to dosing, or the use of any drug within 5 half-lives prior to screening (whichever is longer). Additionally, subjects who plan to take any non-study medications during the trial period will be excluded.
• Any other circumstances that, in the investigator's judgment, make the subject unsuitable for participation in the trial. This includes physiological or psychological conditions that may increase the trial risk, affect the subject's protocol compliance, or impact the subject's ability to complete the study.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 100029, China

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 11, 2025
• Primary Completion: March 21, 2026
• Study Completion: March 21, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-04

Locations

CN (1)