A Phase 1 interventional study of MWX401 1 and MWX401 2 in Essential Hypertension and Healthy Volunteers, sponsored by Shanghai Minwei Biotechnology Co., Ltd. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Shanghai Minwei Biotechnology Co., Ltd (part of Lepu Medical) · Phase 1, Interventional, and Treatment
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.
478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.
This study's planned enrollment of 46 is below the median of 144 across 406 interventional studies indexed under Essential Hypertension.
Browse Essential Hypertension studies →Shanghai Minwei Biotechnology Co., Ltd is the lead sponsor of 21 studies on the registry; 10 are open to participants now.
First submitted after Shanghai Minwei Biotechnology Co., Ltd became part of Lepu Medical.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
5.12-lead results normal or judged by the investigator as abnormal without clinical significance, with (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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: MWX401 1 · Drug: Placebo
Drug: MWX401 2 · Drug: Placebo
Drug: MWX401 3 · Drug: Placebo
Drug: MWX401 4 · Drug: Placebo
Drug: MWX401 5 · Drug: Placebo
Administered subcutaneously (SC)
Administered SC
Administered SC
Administered SC
Administered SC
Administered SC
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence and severity of TEAEs.
Time frame: Through study completion, for at least 85 days
Maximum Concentration (Cmax)
Cmax of MWX401.
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Tmax of MWX401.
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWX401.
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWX401.
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWX401.
Time frame: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Ae of MWX401.
Time frame: Up to 72 hours post-dose
Cumulative Urinary Excretion from 0 to 48 hours (Ae0-48h)
Ae0-48h of MWX401
Time frame: Up to 72 hours post-dose
Fraction of Dose Excreted in Urine (Ae%)
Ae% of MWX401.
Time frame: Up to 72 hours post-dose
Fractional Excretion (Fe)
Fe of MWX401.
Time frame: Up to 72 hours post-dose
Renal Clearance (CLr)
CLr of MWX401.
Time frame: Up to 72 hours post-dose
Change from Baseline in Serum Angiotensinogen (AGT)
Change value and percentage change from baseline in serum AGT.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Day 85
Change from Baseline in Stroke Volume
Change from baseline in stroke volume.
Time frame: Through study completion, for at least 85 days
Change from Baseline in Systemic Vascular Resistance
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Oct 2026, 7 months after the start.
Of 18 phase 1 interventional studies under Essential Hypertension, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 8. This study's planned 7 months is above that.
How these figures are worked out, and which studies are left out of them.
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