Can one shot tame high blood pressure?
NCT ID NCT07803835
First seen Sep 04, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
Researchers are testing a single injection of MWX401 in healthy volunteers and people with mild high blood pressure. The trial aims to see if the drug is safe and how the body processes it. Participants receive one dose or a placebo, and doctors monitor blood pressure and side effects for a period after the injection.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MWX401 injection, a single-dose investigational drug given under the skin
- What this could lead to
- If it works, a single injection of MWX401 could offer a new way to control mild high blood pressure without daily pills.
- What could go wrong
- This is an early, small phase 1 trial focused on safety, so the drug may not lower blood pressure as hoped or may cause side effects. Results in a few dozen people may not apply to everyone.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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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. Male or female participants aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF). 2. Body mass index (BMI) within 19.0 to 30.0 kg/m\^2 (inclusive) at screening, with body weight \>= 50 kg. 3. No use of antihypertensive medications within 30 days prior to signing the ICF, including beta-blockers, angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), angiotensin receptor-neprilysin inhibitors (ARNIs), and diuretics. 4. At screening and baseline, average seated office blood pressure: healthy participants: SBP 120-139 mmHg (inclusive) and DBP 75-89 mmHg (inclusive); participants with mild hypertension: SBP 140-159 mmHg (inclusive) and DBP 90-99 mmHg (inclusive). 5.12-lead electrocardiogram results normal or judged by the investigator as abnormal without clinical significance, with QTcF (Fridericia's formula) \< 450 ms (male) or \< 470 ms (female). 6\. Voluntarily sign the ICF before any study-related procedure, able to understand and willing to comply with the requirements of the study protocol. Exclusion Criteria: 1. History or evidence of secondary hypertension, including renal parenchymal hypertension, renovascular hypertension, aortic stenosis, primary aldosteronism, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, drug-induced hypertension, etc. 2. History of type 1 or type 2 diabetes mellitus. 3. Pulse/heart rate \<55 bpm or \>100 bpm at screening. 4. eGFR (CKD-EPI) \<80 mL/min/1.73 m² at screening. 5. Body weight loss \>5% within 6 months before screening, or planned weight loss during study. 6. History of or current orthostatic hypotension (SBP drop ≥20 mmHg or DBP drop ≥10 mmHg within 1 min of standing from supine). 7. History of syncope before screening. 8. Use of prescription drugs, herbal products, or dietary supplements that may affect safety or data integrity within 30 days before randomization. 9. Excessive blood pressure fluctuation (SBP fluctuation \>20 mmHg during screening). 10. History of needle phobia, difficult blood sampling, or intolerance to venipuncture. 11. Any other condition deemed unsuitable for study by investigator.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Affiliated Sir Run Run Hospital, Nanjing Medical University
RECRUITINGNanjing, Jiangsu, China
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