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

Inclusion criteria

• 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).

• 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

• 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.