A Phase I Single and Multiple Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of HS-10522 in Healthy Chinese Participants and Chinese Participants With Mild Hypertension

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult, Hypertension

In brief

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.

Key facts

Study ID

NCT07609875

Run by

Jiangsu Hansoh Pharmaceutical Co., Ltd.

People needed

88

Starts

2026-06-01

Expected to finish

2027-02-03

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For all participants:
• 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).

You may not qualify if…

• 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.
• 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).
• 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).
• 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.

Full record on ClinicalTrials.gov

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