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

NCT07803835 | Recruiting Phase 1

• 1 other identifier: MWX401-101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Incidence and severity of TEAEs.

  Through study completion, for at least 85 days

Secondary Outcomes (17)

• Maximum Concentration (Cmax)

  Up to 48 hours post-dose

• Time to Reach Maximum Concentration (Tmax)

  Up to 48 hours post-dose

• Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)

  Up to 48 hours post-dose

• Area Under the Curve From Time 0 to Infinity (AUC0-inf)

  Up to 48 hours post-dose

• Elimination Half-Life (t1/2)

  Up to 48 hours post-dose

Study Arms (5)

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

Interventions

MWX401 1 DRUG

Administered subcutaneously (SC)

MWX401 Cohort 1

MWX401 2 DRUG

Administered SC

MWX401 Cohort 2

MWX401 3 DRUG

Administered SC

MWX401 Cohort 3

MWX401 4 DRUG

Administered SC

MWX401 Cohort 4

MWX401 5 DRUG

Administered SC

MWX401 Cohort 5

Placebo DRUG

Administered SC

MWX401 Cohort 1; MWX401 Cohort 2; MWX401 Cohort 3; MWX401 Cohort 4; MWX401 Cohort 5

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).
• 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).
• \. Voluntarily sign the ICF before any study-related procedure, able to understand and willing to comply with the requirements of the study protocol.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

The Affiliated Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wanxiang Chen

CONTACT

+86 13359015677; chenwanxiang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start: March 19, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)