Subjects With Mild HypertensionPhase 1NCT07117474
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.
A Phase 1 study of Subjects With Mild Hypertension, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects With Mild Hypertension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2024to 9 Jun 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- Orthostatic hypotension;
- History of type 2 diabetes mellitus or poorly controlled blood glucose;
- Recently received any antihypertensive medications or medications that affect blood pressure.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
- Conditions
- Subjects With Mild Hypertension
- Being tested
- HRS-9563, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-9563, placeboDrug
A single subcutaneous injection of HRS-9563 injection or placebo was administered
| Study group | Role | What they receive |
|---|---|---|
| Treatment group 1: Injection of HRS-9563 or placebo | Experimental | Not described Receives: Drug: HRS-9563, placebo |
| Treatment group 2: Injection of HRS-9563 or placebo | Experimental | Not described Receives: Drug: HRS-9563, placebo |
| Treatment group 3: Injection of HRS-9563 or placebo | Experimental | Not described Receives: Drug: HRS-9563, placebo |
| Treatment group 4: Injection of HRS-9563 or placebo | Experimental | Not described Receives: Drug: HRS-9563, placebo |
| Treatment group 5: Injection of HRS-9563 or placebo | Experimental | Not described Receives: Drug: HRS-9563, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of any adverse events
Measured: Evaluation was performed up to Day169
Secondary outcomes (9)
Maximum observed plasma concentration of HRS-9563 (Cmax)
Measured: Evaluation was performed up to Day3
Time to Cmax (Tmax)
Measured: Evaluation was performed up to Day3
Area under the concentration-time curve from 0 to the last measurable time point after HRS-9563 administration (AUC0-t)
Measured: Evaluation was performed up to Day3
Area under the concentration-time curve from time 0 to infinity after HRS-9563 administration (AUC0-inf)
Measured: Evaluation was performed up to Day3
Terminal elimination half-life of HRS-9563 (t1/2
Measured: Evaluation was performed up to Day3
Apparent clearance of HRS-9563 (CL/F)
Measured: Evaluation was performed up to Day3
Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F)
Measured: Evaluation was performed up to Day3
Cumulative amount of drug excreted in urine (Ae,urine)
Measured: Evaluation was performed up to Day3
Cumulative percentage of dose recovered in urine (Fe,urine)
Measured: Evaluation was performed up to Day3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start24 Dec 2024
- Primary completion9 Jun 2026
- Study completion9 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subjects With Mild HypertensionStudies of the same condition, open and under way.
- More trials run by Fujian Shengdi Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117474
- Sponsor's protocol ID
- HRS-9563-101
- Status last verified
- Aug 2026
- First submitted
- 9 Jul 2025
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT07117474
- Acronym / sponsor ID
- HRS-9563-101
- Conditions
- Subjects With Mild Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 9 Jun 2026 (actual)
- Study completion
- 9 Jun 2026 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and tolerability of a single subcutaneous injection of HRS-9563 in hypertensive subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment group 1: Injection of HRS-9563 or placebo | Experimental | Drug: HRS-9563, placebo |
| Treatment group 2: Injection of HRS-9563 or placebo | Experimental | Drug: HRS-9563, placebo |
| Treatment group 3: Injection of HRS-9563 or placebo | Experimental | Drug: HRS-9563, placebo |
| Treatment group 4: Injection of HRS-9563 or placebo | Experimental | Drug: HRS-9563, placebo |
| Treatment group 5: Injection of HRS-9563 or placebo | Experimental | Drug: HRS-9563, placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
- Orthostatic hypotension;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-9563, placeboA single subcutaneous injection of HRS-9563 injection or placebo was administered | Drug | Treatment group 1: Injection of HRS-9563 or placebo, Treatment group 2: Injection of HRS-9563 or placebo, Treatment group 3: Injection of HRS-9563 or placebo, Treatment group 4: Injection of HRS-9563 or placebo, Treatment group 5: Injection of HRS-9563 or placebo |
Primary outcome
Incidence and severity of any adverse events
Time frame: Evaluation was performed up to Day169
9 secondary outcomes
Maximum observed plasma concentration of HRS-9563 (Cmax)
Time frame: Evaluation was performed up to Day3
Time to Cmax (Tmax)
Time frame: Evaluation was performed up to Day3
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
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
Terminal elimination half-life of HRS-9563 (t1/2
Time frame: Evaluation was performed up to Day3
Apparent clearance of HRS-9563 (CL/F)
Time frame: Evaluation was performed up to Day3
Apparent volume of distribution during terminal elimination phase of HRS-9563 (Vz/F)
Time frame: Evaluation was performed up to Day3
Cumulative amount of drug excreted in urine (Ae,urine)
Time frame: Evaluation was performed up to Day3
Cumulative percentage of dose recovered in urine (Fe,urine)
Time frame: Evaluation was performed up to Day3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Subjects With Mild Hypertension, run by Fujian Shengdi Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of any adverse events (time frame: Evaluation was performed up to Day169). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.