Safety, Tolerability and Pharmacokinetic Study of HRS-8829 (NCT07083362) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerability and Pharmacokinetic Study of HRS-8829
China83 participantsStarted 2025-08-06
Plain-language summary
This study adopted a single-center, randomized, double-blind, placebo-controlled, dose-escalation design and was divided into three parts: single-dose dose-escalation (SAD) 、 multiple-dose dose-escalation (MAD)、drug-drug interaction（DDI）
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
. Male and female subjects aged 18 to 55 years old
. The weight of female subjects was ≥45 kg, that of male subjects was ≥50 kg, and the body mass index (BMI) was within the range of 19.0-28.0 kg/m2
. The female subjects were not in the pregnancy or lactation period, and the pregnancy examination results before the test were negative; Male or female subjects agreed to take the investigator-approved effective contraceptive measures during the trial as required by the investigator.
. Voluntarily participate in this clinical trial
Exclusion criteria
. Have any history of allergies
. Have had or are currently suffering from diseases of the heart, liver, kidneys, endocrine system, digestive tract, immune system, respiratory system, musculoskeletal system and nervous system, etc
. The electrocardiogram at lead 12 was abnormal and was judged by the researcher as unsuitable to participate in this study
. Those who test positive for any one of hepatitis B surface antigen, hepatitis C antibody, syphilis specific antibody or human immunodeficiency virus antigen-antibody during the screening period
. Those whose screening period examination results are judged by the research doctor as abnormal and of 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.
What they're measuring
1
The incidence and severity of adverse events
Timeframe: From ICF signing date to Day8 after single administration
2
The incidence and severity of adverse events
Timeframe: From ICF signing date to Day15 after multiple administrations
3
The Incidence and severity of adverse events
Timeframe: from the date of ICF signing to the 21st day after DDI administration
. Those who have used any drugs that inhibit or induce liver enzymes within one month before administration
. Those who have used or are currently using any medication within two weeks prior to administration
. Those who have received a vaccine within one month prior to screening (except for the influenza vaccine) or plan to receive a vaccine during the trial period