About this trial
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ascending single and multiple oral doses of HS-10522 in healthy Chinese participants and Chinese participants with mild hypertension.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Able to understand the procedures and methods of the study, willing to strictly adhere to the clinical trial protocol to complete the study, and voluntarily sign the Informed Consent Form (ICF).
Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF.
At screening, body weight ≥ 50 kg for males and ≥ 45 kg for females, with a body mass index (BMI) between 19.0 and 28.0 kg/m² (inclusive).
Disqualifiers
Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator.
Presence of orthostatic hypotension or orthostatic tachycardia at screening.
Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator.
Use of any medication within 2 weeks or 5 half-lives (whichever is longer) prior to screening, or anticipation of needing such medication during the trial.
Trial design
Parallel
Treatments tested in this trial
HS-10522
DrugHS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
HS-10522 Placebo
DrugHS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
Treatment groups
Trial outcomes
Primary outcomes
Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension
Safety and tolerability will be assessed by comparison of number of adverse events between groups
Secondary outcomes
Maximum plasma concentration (Cmax)
time to maximum plasma concentration (Tmax)
area under the curve (AUC)
half-life
Locations
Sponsors and contacts
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