Comparison of HRS-5965 Capsules and Tablets in Healthy Subjects

NCT06490991 | Completed Phase 1

• 1 other identifier: HRS-5965-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paroxysmal Nocturnal Hemoglobinuria，IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• The relative bioavailability (Fr) values between HRS-5965 capsules and HRS-5965 tablets taken on an empty stomach

  0-144hours

• Relative bioavailability (Fr) values of HRS-5965 capsules taken on an empty stomach

  0-144hours

Study Arms (2)

Arm A: Medication regimen 1-2

EXPERIMENTAL

Drug: HRS-5965 tablets；HRS-5965 capsules

Arm B: Medication regimen 2-1

EXPERIMENTAL

Drug: HRS-5965 tablets；HRS-5965 capsules

Interventions

HRS-5965 tablets；HRS-5965 capsules DRUG

Medication regimen: 1 Drug: HRS-5965 tablets Medication regimen: 2 Drug: HRS-5965 capsules

Arm A: Medication regimen 1-2; Arm B: Medication regimen 2-1

Eligibility Criteria

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

You may qualify if:

• 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.
• Healthy subject is male aged between 18 and 45 years (including both ends, subject to signing of informed consent form);
• Body weight ≥ 50 kg, and body mass index (BMI): 19-26 kg/m2 (including both ends);
• 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;
• 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;
• 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);

You may not qualify if:

• 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;
• 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;
• Patients with comorbidities such as cardiovascular, liver, kidney, digestive tract, psychiatric, hematological, metabolic abnormalities, and immunodeficiency;
• Individuals with a history of meningococcal infection or first-degree relatives with a history of meningococcal infection;
• 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;
• Screening for individuals who have experienced severe trauma or surgery within the first 8 weeks, or plan to undergo surgery during the trial period;
• 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);
• 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);
• 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;
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeding the upper limit of normal values (ULN), or total bilirubin exceeding 1.5 times ULN;
• When screening, individuals with QTcF\>450 msec (male) , or other clinically significant abnormalities determined by the researcher;
• 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;
• Those who have used drugs or drugs in the past; Or those who tested positive for urine medication during screening;
• Screening for individuals who smoke an average of 5 or more cigarettes per day within the first 4 weeks;
• 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;

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

ZhongShan Hospital FuDan University

Shanghai, Shanghai Municipality, 200032, China

Location

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: June 23, 2024
• First Posted: July 8, 2024
• Study Start: July 17, 2024
• Primary Completion: August 6, 2024
• Study Completion: September 10, 2024
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

CN (1)