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NCT Number: NCT07609875

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-

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).

Exclusion criteria

  • 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.

Treatment and study plan

HS-10522

Drug

HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily

HS-10522 Placebo

Drug

HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily

Primary outcomes

  1. Incidence of adverse events following single and multiple doses of HS-10522 in healthy participants and participants with mild hypertension

    Time frame: 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 outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: -0.5 to 120 hour after dosing

  2. time to maximum plasma concentration (Tmax)

    Time frame: -0.5 to 120 hour after dosing

  3. area under the curve (AUC)

    Time frame: -0.5 to 120 hour after dosing

  4. half-life

    Time frame: -0.5 to 120 hour after dosing

  5. apparent volume of distribution (Vz/F)

    Time frame: -0.5 to 120 hour after dosing

  6. apparent oral clearance (CL/F) of HS-10522

    Time frame: -0.5 to 120 hour after dosing

  7. Plasma aldosterone following single and multiple oral doses of HS-10522

    Time frame: 0 to 96 hour after dosing

  8. Cortisol following single and multiple oral doses of HS-10522

    Time frame: 0 to 96 hour after dosing

  9. Metabolites levels following single and multiple oral doses of HS-10522

    Time frame: 0 to 96 hour after dosing

  10. (Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline

    Time frame: 14 days after dosing

    Blood pressure measurement will be performed only in MAD part

Sponsors and collaborators

Lead sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 27, 2026
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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