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Not yet recruiting 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

Phase I Interventional Healthy Adult Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HS-10522, HS-10522 Placebo.
Who it may be relevant to
Registry conditions: Healthy Adult, Hypertension. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • Drug HS-10522
    HS-10522 tablet, oral, single ascending dose and multiple ascending dose, once daily
  • Drug HS-10522 Placebo
    HS-10522 placebo , oral, single ascending dose and multiple ascending dose, once daily

Primary outcome measures

  • 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]
Secondary outcome measures (10)
  • Maximum plasma concentration (Cmax) [Time frame: -0.5 to 120 hour after dosing]
  • time to maximum plasma concentration (Tmax) [Time frame: -0.5 to 120 hour after dosing]
  • area under the curve (AUC) [Time frame: -0.5 to 120 hour after dosing]
  • half-life [Time frame: -0.5 to 120 hour after dosing]
  • apparent volume of distribution (Vz/F) [Time frame: -0.5 to 120 hour after dosing]
  • apparent oral clearance (CL/F) of HS-10522 [Time frame: -0.5 to 120 hour after dosing]
  • Plasma aldosterone following single and multiple oral doses of HS-10522 [Time frame: 0 to 96 hour after dosing]
  • Cortisol following single and multiple oral doses of HS-10522 [Time frame: 0 to 96 hour after dosing]
  • Metabolites levels following single and multiple oral doses of HS-10522 [Time frame: 0 to 96 hour after dosing]
  • (Exploratory) Mean seated systolic and diastolic blood pressure change compared with baseline [Time frame: 14 days after dosing]

Eligibility criteria

Inclusion criteria

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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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07609875 · HS-10522-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗