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 range18 Years – 55 Years
SexALL
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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
✕. Those who have used any drugs that inhibit or induce liver enzymes within one month before administration
✕
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 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