A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 … (NCT06684041) | Clinical Trial Compass
CompletedPhase 1
A Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Study, and QT Interval Study of HRS-5965 Capsules in Healthy Subjects
China32 participantsStarted 2024-11-09
Plain-language summary
This was a randomized, double-blind, single-dose, placebo-controlled phase I clinical trial. This study plans to conduct three dose groups of dose 1, dose 2, and dose 3. A total of 32 healthy subjects were planned to be enrolled.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the informed consent form before any activities related to this trial, be able to understand the procedures and methods of this trial, and be willing to complete this trial in strict accordance with the clinical trial protocol.
. Aged between 18 and 45 years old (based on the time of signing the informed consent form), both males and females are eligible.
. The body weight of males ≥ 50 kg, and that of females ≥ 45 kg, and body mass index (BMI): 19 - 26 kg/m².
. During the screening period, there are no abnormalities in physical examination, vital signs, twelve - lead electrocardiogram, frontal and lateral chest radiographs, abdominal ultrasound, and laboratory tests, or those with minor abnormalities but judged by the investigator to be of no clinical significance.
. During the screening period, human immunodeficiency virus antibody (HIV - Ab), treponema pallidum antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus antibody (HCV - Ab) are all negative.
. Complete the vaccination of Neisseria meningitidis and Streptococcus pneumoniae vaccines 2 weeks before the first administration of HRS - 5965.
Exclusion criteria
. The researcher has determined that there may be diseases or medical conditions that affect the absorption, distribution, metabolism and excretion of drugs or reduce compliance.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of subjects with adverse events (AEs)
Timeframe: Baseline up to seven days after the last dosing.
2
QTcF: Baseline and placebo-adjusted QTcF after oral HRS-5965 capsules
. According to the judgment of the researcher, any physiological or psychological disease or condition that may increase the risk of the test, affect the subject's compliance with the protocol, or affect the subject's completion of the test.
. Those with a previous history of Neisseria meningitidis infection, or those whose first - degree relatives have a history of Neisseria meningitidis infection.
. Those with definite evidence of infection within 2 weeks before screening (positive etiological examination, or having received systemic antibiotic treatment), or those who have had a body temperature exceeding 38 °C.
. Subjects with abnormal serum electrolytes (hypokalemia, hypomagnesemia, hypocalcemia).
. Subjects with a history of convulsive disorders, long QT syndrome (including family history), syncope while swimming or any other type of syncope or history of loss of consciousness.
. Subjects with a previous history of heart disease, such as hypertension, atherosclerosis, heart failure, bradycardia or stroke, or those using a pacemaker.
. Those with a serum creatinine level exceeding the upper limit of the normal value, or those whose level does not exceed the upper limit but are judged by the investigator to be at risk of renal function impairment.