One shot to tame blood pressure? new drug HRS-9563 heads into first human test
NCT ID NCT07117474
First seen Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time
Summary
This early-stage trial is testing whether a single injection of an experimental drug called HRS-9563 is safe and tolerable for people with mild high blood pressure. About 60 adults aged 18 to 65 with mild hypertension will receive either the drug or a placebo, and researchers will track any side effects and how the drug moves through the body. The goal is to gather initial safety data to support further development of this potential new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HRS-9563, an experimental drug given as a single subcutaneous injection
- What this could lead to
- If successful, this could lead to a new, convenient once-only injection option for managing mild hypertension, potentially improving blood pressure control with fewer daily pills.
- What could go wrong
- This is an early Phase 1 trial focused on safety, not effectiveness. The drug may not lower blood pressure enough, and side effects are still unknown. Results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
60 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Males or infertile women aged 18-65 years (inclusive); 2. Body mass index in the range of 19-28 kg/m2 (inclusive); 3. 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. Exclusion Criteria: 1. Abnormal daily life rhythm; 2. Any blood biochemical indicator during screening or baseline did not meet the standards in the exclusion criteria; 3. Secondary hypertension; 4. Mean sitting diastolic blood pressure ≥ 100 mmHg; 5. Orthostatic hypotension; 6. History of type 2 diabetes mellitus or poorly controlled blood glucose; 7. Recently received any antihypertensive medications or medications that affect blood pressure.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 314408, China