Capsule vs tablet: which form of HRS-5965 works best?
NCT ID NCT06490991
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This completed Phase 1 trial tested 16 healthy adults to compare how well HRS-5965 is absorbed when taken as a capsule versus a tablet. The goal was to measure relative bioavailability on an empty stomach. This is a preliminary step before testing the drug in patients with blood or kidney disorders.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-5965
- What this could lead to
- If successful, this could help determine the best form (capsule or tablet) for future studies of HRS-5965 in conditions like paroxysmal nocturnal hemoglobinuria and IgA nephropathy.
- What could go wrong
- This is a very early, small study in healthy people, not patients. It only measures how the drug is absorbed, not whether it works for any disease. Results may not predict effectiveness or safety in patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Sep 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, 200032, China