MWX401 Injection in healthy adults and people with mild hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase 1 trial. It aims to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWX401 across five dose cohorts in healthy volunteers and in participants with mild hypertension. Primary endpoint is the incidence and severity of treatment-emergent adverse events, while secondary endpoints include PK/PD parameters, changes in RAAS-related biomarkers, blood pressure and hemodynamics, and immunogenicity indicators. Enrollment targets 46 subjects, with inclusion criteria emphasizing adults aged 18-60, BMI 19-30, and blood pressure ranges aligned to group status. The study is sponsored by Shanghai Minwei Biotechnology Co., with the Affiliated Sir Run Run Hospital at Nanjing Medical University as the site.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Affiliated Sir Run Run Hospital, Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Wanxiang Chen
• Email: chenwanxiang@minweibiotech.com
• Phone: +86 13359015677

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.