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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorJiangsu Hansoh Pharmaceutical Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: HS-10522Experimental treatment 1 intervention
Group B: HS-10522 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
SAD: 0 to 7 days after dosing; MAD: 0 to 14 days after dosing

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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