Healthy Adult, Hypertension
Conditions
Keywords
hypertension
Brief summary
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.
Interventions
DRUGHS-10522
HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
DRUGHS-10522 Placebo
HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
\- For all participants: 1. 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). 2. Male or female participants aged 18 to 55 years (inclusive) at the time of signing ICF. 3. 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).
Exclusion criteria
1. Abnormal vital signs, physical examination findings, or laboratory test results at screening that are deemed clinically significant by the investigator. 2. Presence of orthostatic hypotension or orthostatic tachycardia at screening. 3. Clinically significant abnormal findings on the 12-lead ECG at screening, as judged by the investigator. 4. 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. 5. Known secondary causes of hypertension, or diseases that may affect adrenal function (e.g., renal artery stenosis, poorly controlled or untreated hyperthyroidism, poorly controlled or untreated hypothyroidism, hyperparathyroidism, pheochromocytoma, Cushing's syndrome). 6. Participation in any other clinical trial of a drug or medical device within 12 weeks prior to screening, with receipt of at least one dose (including placebo), or currently within 5 half-lives of the last dose of the investigational product (whichever is longer). 7. Participants who, in the opinion of the investigator, are likely to be non-compliant or are unsuitable for participation in this trial for any other reason.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension | SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing | Safety and tolerability will be assessed by comparison of number of adverse events between groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | -0.5 to 120 hour after dosing | — |
| time to maximum plasma concentration (Tmax) | -0.5 to 120 hour after dosing | — |
| area under the curve (AUC) | -0.5 to 120 hour after dosing | — |
| half-life | -0.5 to 120 hour after dosing | — |
| apparent volume of distribution (Vz/F) | -0.5 to 120 hour after dosing | — |
| apparent oral clearance (CL/F) of HS-10522 | -0.5 to 120 hour after dosing | — |
| Plasma aldosterone following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing | — |
| Cortisol following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing | — |
| Metabolites levels following single and multiple oral doses of HS-10522 | 0 to 96 hour after dosing | — |
| (Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline | 14 days after dosing | Blood pressure measurement will be performed only in MAD part |
Outcome results
None listed