Phase 1 Clinical Study of MWX401 Injection in Chinese Healthy Participants and Participants With Mild Hypertension

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.

Study Overview

• Status: Recruiting
• Conditions: Essential Hypertension; Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: MWX401 1; Drug: MWX401 2; Drug: MWX401 3; Drug: MWX401 4; Drug: MWX401 5

• Study Type: Interventional
• Enrollment (Estimated): 46
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Wanxiang Chen; Phone Number: +86 13359015677; Email: chenwanxiang@minweibiotech.com

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • The Affiliated Sir Run Run Hospital, Nanjing Medical University
      • Contact: Yuwen Su, Doctor; Phone Number: +86 13776688046; Email: 13776688046@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MWX401 Cohort 1	Drug: Placebo; Administered SC; Drug: MWX401 1; Administered subcutaneously (SC)
Experimental: MWX401 Cohort 2	Drug: Placebo; Administered SC; Drug: MWX401 2; Administered SC
Experimental: MWX401 Cohort 3	Drug: Placebo; Administered SC; Drug: MWX401 3; Administered SC
Experimental: MWX401 Cohort 4	Drug: Placebo; Administered SC; Drug: MWX401 4; Administered SC
Experimental: MWX401 Cohort 5	Drug: Placebo; Administered SC; Drug: MWX401 5; Administered SC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)	Incidence and severity of TEAEs.	Through study completion, for at least 85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax)	Cmax of MWX401.	Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)	Tmax of MWX401.	Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)	AUC0-t of MWX401.	Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)	AUC0-inf of MWX401.	Up to 48 hours post-dose
Elimination Half-Life (t1/2)	t1/2 of MWX401.	Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)	Ae of MWX401.	Up to 72 hours post-dose
Cumulative Urinary Excretion from 0 to 48 hours (Ae0-48h)	Ae0-48h of MWX401	Up to 72 hours post-dose
Fraction of Dose Excreted in Urine (Ae%)	Ae% of MWX401.	Up to 72 hours post-dose
Fractional Excretion (Fe)	Fe of MWX401.	Up to 72 hours post-dose
Renal Clearance (CLr)	CLr of MWX401.	Up to 72 hours post-dose
Change from Baseline in Serum Angiotensinogen (AGT)	Change value and percentage change from baseline in serum AGT.	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 biomarkers.	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.	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.	Up to Day 85
Change from Baseline in Stroke Volume	Change from baseline in stroke volume.	Through study completion, for at least 85 days
Change from Baseline in Systemic Vascular Resistance	Change from baseline in systemic vascular resistance.	Through study completion, for at least 85 days
Detect anti-drug antibodies (ADA) and their titers		Through study completion, for at least 85 days

Collaborators and Investigators

• Sponsor: Shanghai Minwei Biotechnology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 1, 2026
• First Submitted That Met QC Criteria: September 1, 2026
• First Posted (Actual): September 4, 2026

Study Record Updates

• Last Update Posted (Actual): September 4, 2026
• Last Update Submitted That Met QC Criteria: September 1, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: MWX401-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No