Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Subcutaneous Injection of HRS-9563 in Subjects With Mild Hypertension: a Randomized, Double-blind, Placebo-controlled Phase I Study.

ConditionSubjects With Mild Hypertension

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorFujian Shengdi Pharmaceutical Co., Ltd.

About this trial

To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects

Eligibility criteria

Qualifiers

Males or infertile women aged 18-65 years (inclusive);

Body mass index in the range of 19-28 kg/m2 (inclusive);

Mild primary hypertension, without antihypertensive treatment, with a mean sitting systolic blood pressure ≥ 130 mmHg and ≤ 159 mmHg during screening and baseline, and a mean 24-hour ambulatory systolic blood pressure ≥ 130 mmHg during screening.

Disqualifiers

Abnormal daily life rhythm;

Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria;

Secondary hypertension;

Mean sitting diastolic blood pressure ≥ 100 mmHg;

Trial design

Treatments tested in this trial

HRS-9563, placebo

Treatment groups

60 Participants

are divided into 5 treatment groups

Sponsors and collaborators

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov