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

A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Oral Doses of HS-10522 Tablets in Healthy Chinese Participants and Chinese Participants With Mild Hypertension

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension; Healthy Adult
• Intervention / Treatment: Drug: HS-10522; Drug: HS-10522 Placebo

• Study Type: Interventional
• Enrollment (Estimated): 88
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-10522	Drug: HS-10522; HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
Placebo Comparator: HS-10522 Placebo	Drug: HS-10522 Placebo; HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Blood pressure measurement will be performed only in MAD part	14 days after dosing

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): February 3, 2027

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 27, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypertension
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension
• Other Study ID Numbers: HS-10522-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No