A Phase I Clinical Study of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects (NCT06732154) | Clinical Trial Compass
CompletedPhase 1
A Phase I Clinical Study of a Single Subcutaneous Injection of HRS-5632 in Healthy Subjects
China50 participantsStarted 2024-12-02
Plain-language summary
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HRS-5632 Following a Single Subcutaneous Injection in Healthy Subjects
Who can participate
Age range
18 Years – 55 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
. Understand the specific procedures of the trial, voluntarily participate in this trial, and sign an informed consent form;
. Age on the day of signing the informed consent form must be ≥18 and ≤55 years old (inclusive of boundary values);
. Male subjects must weigh ≥50 kg and female subjects must weigh ≥45 kg, with a Body Mass Index (BMI) within the range of 19 to 30 kg/m² (inclusive of boundary values);
. Female subjects with childbearing potential must agree to use effective contraception and avoid donating eggs from the time of signing the informed consent form until the end of the trial. Serum pregnancy tests within 7 days before the first dosing and during the trial must be negative, and they must not be breastfeeding; Male subjects with partners who have childbearing potential must agree to use effective contraception and avoid donating sperm from the time of signing the informed consent form until 6 months after the last administration of the trial medication;
. Vital signs, physical examinations, and laboratory tests (complete blood count, urinalysis, blood biochemistry, coagulation function, thyroid function, sex hormones), 12-lead electrocardiogram, chest X-ray, and abdominal ultrasound must be normal or have abnormalities without clinical significance.
Exclusion criteria
. Subjects with any clinically significant diseases or medical history in the circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic systems, or any other diseases or histories that could interfere with the trial results or any significant laboratory abnormalities judged by the investigator to be clinically meaningful;
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
The percentage of all reported adverse events, serious adverse events and treatment-related adverse events, serious adverse events.
Timeframe: from the single dose administration (Day 1) to Day 337
. Use of any prescription, over-the-counter, or traditional Chinese medicine within 14 days prior to the study drug administration, or within 7 half-lives of the drug at the time of screening;
. Participation in any clinical trial of drugs or medical devices within the last 3 months, or still within 7 half-lives of the drug at the time of screening (the longer standard shall prevail if both are met);
. Subjects who plan to take lipid-lowering or lipid-affecting drugs not part of this study during the trial;
. Elevated high-sensitivity C-reactive protein \>1.5 times the upper limit of normal, or prothrombin time/international normalized ratio (PT/INR), activated partial thromboplastin time (APTT) \>1.25 times the upper limit of normal during the screening period;
. Positive results in infectious disease screening (including hepatitis B surface antigen (HBsAg), hepatitis C virus antibody, human immunodeficiency virus antibody, syphilis spirochete antibody);
. Abnormal 12-lead electrocardiogram with clinical significance, or electrocardiogram QT interval (QTcF) \> 450 ms in males, \> 470 ms in females;