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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
46
Administered subcutaneously (SC)
Administered SC
Administered SC
Administered SC
Administered SC
Administered SC
The Affiliated Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGIncidence 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
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