A Single Ascending Dose of HRS-2162 in Healthy Subjects (NCT07195604) | Clinical Trial Compass
RecruitingPhase 1
A Single Ascending Dose of HRS-2162 in Healthy Subjects
China64 participantsStarted 2025-09-25
Plain-language summary
The study is being conducted to evaluate the safety and tolerability of HRS-2162 injection in a single dose in healthy subjects, as well as the characteristics of PK/PD
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
. The subjects voluntarily signed the informed consent form.
. Applicants must be between 18 and 45 years old at the time of signing the informed consent form, and both men and women are eligible .
. ASA classification is Grade I (only Parts Two and three)
. Male weight ≥50 kg, female weight ≥45 kg, body mass index between 19 and 28 kg/m ².
. Adopt efficient contraceptive measures
Exclusion criteria
. Those with a past or current clinical acute or chronic disease
. Those with a history of hereditary bleeding or coagulation disorders or non-traumatic bleeding .
. Those with a history of neuromuscular diseases or poliomyelitis
. Those with a history of anesthesia complications.
. Those whose laboratory test results during the screening period or baseline period exceed the normal range and have clinical significance
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.
. The blood pressure of the subjects was abnormal and was judged by the researchers to be of clinical significance
. The subject has a history of severe systemic allergies for any reason.
. The subjects took steroid hormone drugs within 7 half-lives or 14 days before administrationSmoke ≥5 cigarettes per day within 3 months prior to the study.