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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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • HRS-9563, placebo

    Drug

    A single subcutaneous injection of HRS-9563 injection or placebo was administered

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: Treatment group 1: Injection of HRS-9563 or placeboExperimental treatment 1 intervention
Group B: Treatment group 2: Injection of HRS-9563 or placeboExperimental treatment 1 intervention
Group C: Treatment group 3: Injection of HRS-9563 or placeboExperimental treatment 1 intervention
Group D: Treatment group 4: Injection of HRS-9563 or placeboExperimental treatment 1 intervention
Group E: Treatment group 5: Injection of HRS-9563 or placeboExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of any adverse events

Time frame
Evaluation was performed up to Day169

Secondary outcomes

1

Maximum observed plasma concentration of HRS-9563 (Cmax)

Time frame
Evaluation was performed up to Day3
2

Time to Cmax (Tmax)

Time frame
Evaluation was performed up to Day3
3

Area under the concentration-time curve from 0 to the last measurable time point after HRS-9563 administration (AUC0-t)

Time frame
Evaluation was performed up to Day3
4

Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf)

Time frame
Evaluation was performed up to Day3

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Shengdi Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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