Essential HypertensionPhase 1NCT07803835
Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension
A Phase 1 study testing MWX401 1, MWX401 2 and MWX401 3 in people with Essential Hypertension and Healthy Volunteers, run by Shanghai Minwei Biotechnology Co., Ltd at 1 site in China.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Healthy Volunteers
- What is being tested?
- MWX401 1, MWX401 2 and MWX401 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 19 Mar 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) within 19.0 to 30.0 kg/m^2 (inclusive) at screening, with body weight >= 50 kg.
- 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.
- 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.
Who cannot join
- 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.
- History of type 1 or type 2 diabetes mellitus.
- Pulse/heart rate <55 bpm or >100 bpm at screening.
- eGFR (CKD-EPI) <80 mL/min/1.73 m² at screening.
- Body weight loss >5% within 6 months before screening, or planned weight loss during study.
- History of or current orthostatic hypotension (SBP drop ≥20 mmHg or DBP drop ≥10 mmHg within 1 min of standing from supine).
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- History of syncope before screening.
- Use of prescription drugs, herbal products, or dietary supplements that may affect safety or data integrity within 30 days before randomization.
- Excessive blood pressure fluctuation (SBP fluctuation >20 mmHg during screening).
- History of needle phobia, difficult blood sampling, or intolerance to venipuncture.
- Any other condition deemed unsuitable for study by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu
Yuwen Su, Doctor, +86 13776688046, 13776688046@163.com
About this study
Official title: A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild hypertension.
The study comprises five dose cohorts with a planned enrollment of 46 subjects. The primary endpoint is the incidence and severity of treatment-emergent adverse events. Secondary endpoints include plasma and urinary PK parameters, changes in serum AGT and RAAS components, changes in blood pressure and hemodynamics, and immunogenicity indicators.
- Conditions
- Essential Hypertension, Healthy Volunteers
- Being tested
- MWX401 1, MWX401 2, MWX401 3, MWX401 4, MWX401 5
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MWX401 1Drug
Administered subcutaneously (SC)
MWX401 2Drug
Administered SC
MWX401 3Drug
Administered SC
MWX401 4Drug
Administered SC
MWX401 5Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| MWX401 Cohort 1 | Experimental | Not described Receives: Drug: MWX401 1; Drug: Placebo |
| MWX401 Cohort 2 | Experimental | Not described Receives: Drug: MWX401 2; Drug: Placebo |
| MWX401 Cohort 3 | Experimental | Not described Receives: Drug: MWX401 3; Drug: Placebo |
| MWX401 Cohort 4 | Experimental | Not described Receives: Drug: MWX401 4; Drug: Placebo |
| MWX401 Cohort 5 | Experimental | Not described Receives: Drug: MWX401 5; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence and severity of TEAEs.
Measured: Through study completion, for at least 85 days
Secondary outcomes (17)
Maximum Concentration (Cmax)
Cmax of MWX401.
Measured: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Tmax of MWX401.
Measured: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWX401.
Measured: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWX401.
Measured: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWX401.
Measured: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Ae of MWX401.
Measured: Up to 72 hours post-dose
Cumulative Urinary Excretion from 0 to 48 hours (Ae0-48h)
Ae0-48h of MWX401
Measured: Up to 72 hours post-dose
Fraction of Dose Excreted in Urine (Ae%)
Ae% of MWX401.
Measured: Up to 72 hours post-dose
Fractional Excretion (Fe)
Fe of MWX401.
Measured: Up to 72 hours post-dose
Renal Clearance (CLr)
CLr of MWX401.
Measured: Up to 72 hours post-dose
Change from Baseline in Serum Angiotensinogen (AGT)
Change value and percentage change from baseline in serum AGT.
Measured: Through study completion, for at least 85 days
Change from Baseline in Other RAAS Component Biomarkers
Change value and percentage change from baseline in other RAAS component (PRA, PRC, Ang I, Ang II, or ALD) biomarkers.
Measured: Through study completion, for at least 85 days
Change from Baseline in Blood Pressure
Change in systolic and diastolic blood pressure from baseline throughout the study.
Measured: Through study completion, for at least 85 days
Change from Baseline in 24-hour Ambulatory Blood Pressure
Changes in mean systolic and mean diastolic blood pressure from baseline throughout the study.
Measured: Up to Day 85
Change from Baseline in Stroke Volume
Change from baseline in stroke volume.
Measured: Through study completion, for at least 85 days
Change from Baseline in Systemic Vascular Resistance
Change from baseline in systemic vascular resistance.
Measured: Through study completion, for at least 85 days
Detect anti-drug antibodies (ADA)
Measured: Through study completion, for at least 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start19 Mar 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential HypertensionStudies of the same condition, open and under way.
- More trials run by Shanghai Minwei Biotechnology Co., LtdThe 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minwei Biotechnology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803835
- Sponsor's protocol ID
- MWX401-101
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Administration of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension
- ClinicalTrials.gov ID
- NCT07803835
- Acronym / sponsor ID
- MWX401-101
- Conditions
- Essential Hypertension, Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Shanghai Minwei Biotechnology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Sep 2026 (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.
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase 1 clinical study, aimed at evaluating the safety, tolerability, PK, PD and immunogenicity of single subcutaneous administration of MWX401 Injection in healthy Chinese participants and participants with primary mild hypertension.
The study comprises five dose cohorts with a planned enrollment of 46 subjects. The primary endpoint is the incidence and severity of treatment-emergent adverse events. Secondary endpoints include plasma and urinary PK parameters, changes in serum AGT and RAAS components, changes in blood pressure and hemodynamics, and immunogenicity indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| MWX401 Cohort 1 | Experimental | Drug: MWX401 1, Drug: Placebo |
| MWX401 Cohort 2 | Experimental | Drug: MWX401 2, Drug: Placebo |
| MWX401 Cohort 3 | Experimental | Drug: MWX401 3, Drug: Placebo |
| MWX401 Cohort 4 | Experimental | Drug: MWX401 4, Drug: Placebo |
| MWX401 Cohort 5 | Experimental | Drug: MWX401 5, Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female participants aged 18 to 60 years (inclusive) at the time of signing the informed consent form (ICF).
- Body mass index (BMI) within 19.0 to 30.0 kg/m^2 (inclusive) at screening, with body weight >= 50 kg.
- 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.
- 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).
Key exclusion criteria (11 listed)
- 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.
- History of type 1 or type 2 diabetes mellitus.
- Pulse/heart rate <55 bpm or >100 bpm at screening.
- eGFR (CKD-EPI) <80 mL/min/1.73 m² at screening.
- Body weight loss >5% within 6 months before screening, or planned weight loss during study.
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 |
|---|---|---|
| MWX401 1Administered subcutaneously (SC) | Drug | MWX401 Cohort 1 |
| MWX401 2Administered SC | Drug | MWX401 Cohort 2 |
| MWX401 3Administered SC | Drug | MWX401 Cohort 3 |
| MWX401 4Administered SC | Drug | MWX401 Cohort 4 |
| MWX401 5Administered SC | Drug | MWX401 Cohort 5 |
| PlaceboAdministered SC | Drug | MWX401 Cohort 1, MWX401 Cohort 2, MWX401 Cohort 3, MWX401 Cohort 4, MWX401 Cohort 5 |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, for at least 85 days
Incidence and severity of TEAEs.
17 secondary outcomes
Maximum Concentration (Cmax)
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
Time frame: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Time frame: Up to 72 hours post-dose
Cumulative Urinary Excretion from 0 to 48 hours (Ae0-48h)
Time frame: Up to 72 hours post-dose
Fraction of Dose Excreted in Urine (Ae%)
Time frame: Up to 72 hours post-dose
Fractional Excretion (Fe)
Time frame: Up to 72 hours post-dose
Renal Clearance (CLr)
Time frame: Up to 72 hours post-dose
Change from Baseline in Serum Angiotensinogen (AGT)
Time frame: Through study completion, for at least 85 days
Change from Baseline in Other RAAS Component Biomarkers
Time frame: Through study completion, for at least 85 days
Change from Baseline in Blood Pressure
Time frame: Through study completion, for at least 85 days
Change from Baseline in 24-hour Ambulatory Blood Pressure
Time frame: Up to Day 85
Change from Baseline in Stroke Volume
Time frame: Through study completion, for at least 85 days
Change from Baseline in Systemic Vascular Resistance
Time frame: Through study completion, for at least 85 days
Detect anti-drug antibodies (ADA)
Time frame: Through study completion, for at least 85 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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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.
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 testing MWX401 1, MWX401 2 and MWX401 3 in people with Essential Hypertension and Healthy Volunteers, run by Shanghai Minwei Biotechnology 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 6 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 8 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wanxiang Chen (+86 13359015677, chenwanxiang@minweibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Through study completion, for at least 85 days). 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 8 Sep 2026.