Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects

December 22, 2025 updated by: Chengdu Suncadia Medicine Co., Ltd.

A Clinical Study Evaluating the Relative Bioavailability of HRS-5965 Capsules and Tablets in Healthy Subjects .

The study is designed as a single-center, randomized, open-label, cross-over phase I clinical trial with the intention of recruiting 16 healthy subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200032
        • Zhongshan Hospital Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Voluntarily sign an informed consent form before the start of this trial, and be able to understand the procedures and methods of this trial. Willing to strictly follow the clinical trial protocol to complete this trial.
  2. Healthy subject is male aged between 18 and 45 years (including both ends, subject to signing of informed consent form);
  3. Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (including both ends);
  4. Physical examination, vital signs, 12 lead electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests during the screening period show no abnormalities, or there are slight abnormalities that have been determined by the researcher to have no clinical significance;
  5. Human immunodeficiency virus antibody (HIV Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) were all negative during the screening period;
  6. Male subjects with partners who are fertile women, who have no plans to conceive or donate sperm within 3 months after signing the informed consent form and voluntarily adopt efficient contraceptive measures (including partners);

Exclusion Criteria:

  1. Individuals who are allergic to two or more allergens, or who have been determined by the researcher to be potentially allergic to the investigational drug or its components;
  2. According to the judgment of researchers, there may be diseases or medical conditions that may affect drug absorption, distribution, metabolism, and excretion, or may reduce compliance;
  3. Patients with comorbidities such as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities, and immunodeficiency;
  4. Individuals with a history of meningococcal infection or first-degree relatives with a history of meningococcal infection;
  5. Screening for individuals with clear evidence of infection (positive pathogen test or previous systemic antibiotic treatment) or those with a body temperature exceeding 38 ℃ within the first two weeks;
  6. Screening for individuals who have experienced severe trauma or surgery within the first 8 weeks, or plan to undergo surgery during the trial period;
  7. Screening for clinical trials involving any other drugs or medical devices within the first 4 weeks or planned during the study period, or those who are still within 5 half-lives of the drugs before screening (whichever is longer);
  8. Those who have used any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, traditional Chinese patent medicines and simple preparations and dietary supplements) within 4 weeks before screening; Or select those who are within 5 half-lives of the drug at the time of screening (whichever is longer);
  9. Those whose blood creatinine levels exceed the upper limit of normal values, or those who have not exceeded the upper limit but have been determined by the researcher to have a possibility of renal function damage;
  10. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal values (ULN), or total bilirubin exceeding 1.5 times ULN;
  11. When screening, individuals with QTcF>450 msec (male) , or other clinically significant abnormalities determined by the researcher;
  12. Individuals with a history of blood donation or severe blood loss (blood loss ≥ 400 mL) within the 8 weeks prior to screening, or those who have received blood transfusions within the 12 weeks prior to screening;
  13. Those who have used drugs or drugs in the past; Or those who tested positive for urine medication during screening;
  14. Screening for individuals who smoke an average of 5 or more cigarettes per day within the first 4 weeks;
  15. The average daily alcohol intake in the four weeks before screening exceeds 15 g (15 g alcohol is equivalent to 450 mL beer, 150 mL wine or 50 mL low alcohol Baijiu), or the alcohol breath test is positive during screening;
  16. Difficulty swallowing, difficulty in venous blood collection, or physical condition unable to withstand blood collection; Or subjects who are expected to be unable to complete the entire trial follow-up;
  17. Those who receive the vaccine within 2 weeks before the first administration or within 1 month after the last administration during the study period;
  18. Subjects with a history of recurrent oral ulcers;
  19. According to the judgment of the researcher, any physiological or psychological illness or condition that may increase the trial risk, affect the participant's compliance with the protocol, or affect the participant's completion of the trial, as well as any other situation determined by the researcher that the participant is not suitable to participate in the clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm A: Medication regimen 1-2
Drug: HRS-5965 tablets；HRS-5965 capsules
Medication regimen: 1 Drug: HRS-5965 tablets Medication regimen: 2 Drug: HRS-5965 capsules
Experimental: Arm B: Medication regimen 2-1
Drug: HRS-5965 tablets；HRS-5965 capsules
Medication regimen: 1 Drug: HRS-5965 tablets Medication regimen: 2 Drug: HRS-5965 capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach
Time Frame: 0-144hours
0-144hours
Relative bioavailability (Fr) values of HRS-5965 capsules taken on an empty stomach
Time Frame: 0-144hours
0-144hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chengdu Suncadia Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 6, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRS-5965-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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