This Phase I clinical study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single oral dose of HRS-4139 in healthy participants.
Participants who understand the specific procedures of the trial, voluntarily agree to participate in this trial, and provide written informed consent.
Participants aged 18 to 55 years (inclusive) at screening.
Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) between 18.0 and 26.0 kg/m² (inclusive).
Participants who are able to communicate effectively with the investigator, fully understand and comply with all requirements of the trial protocol.
Participants with any disease of the circulatory, endocrine, neurological, digestive, respiratory, hematologic, immunologic, psychiatric, or metabolic systems, or any other condition that may interfere with the trial results.
Participants with a history of malignancy.
Participants with a history of risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia), or with short QT syndrome or long QT syndrome, or with a family history in first-degree relatives of unexplained sudden death, drowning, or sudden infant death syndrome (SIDS) occurring at ≤ 40 years of age.
Participants who have had an opportunistic infection within 6 months prior to screening; or who have a known history of recurrent or chronic infections, or who have had chronic or recurrent sinusitis, tonsillitis, urinary tract infections, prostatitis, enteritis, etc.
Parallel
HRS-4139 Tablet
DrugHRS-4139 tablet.
HRS-4139 Placebo
DrugHRS-4139 placebo.
Adverse events (AEs)
Serious Adverse events (SAEs)
Plasma concentration of HRS-4139 in healthy participants
Peak concentration (Cmax)
PK parameter.
Time to peak concentration (Tmax)
PK parameter.
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC0-last)
PK parameter.
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