Health TrialsbyHealthPanel

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

ConditionsEssential HypertensionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorShanghai Minwei Biotechnology Co., Ltd

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m² (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).

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MWX401 1

    Drug

    Administered subcutaneously (SC)

  • MWX401 2

    Drug

    Administered SC

  • MWX401 3

    Drug

    Administered SC

  • MWX401 4

    Drug

    Administered SC

  • MWX401 5

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

46 Participants
are divided into 5 treatment groups
Group A: MWX401 Cohort 1Experimental treatment 2 interventions
Group B: MWX401 Cohort 2Experimental treatment 2 interventions
Group C: MWX401 Cohort 3Experimental treatment 2 interventions
Group D: MWX401 Cohort 4Experimental treatment 2 interventions
Group E: MWX401 Cohort 5Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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

Incidence and severity of TEAEs.

Time frame
Through study completion, for at least 85 days

Secondary outcomes

1

Maximum Concentration (Cmax)

Cmax of MWX401.

Time frame
Up to 48 hours post-dose
2

Time to Reach Maximum Concentration (Tmax)

Tmax of MWX401.

Time frame
Up to 48 hours post-dose
3

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
4

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

AUC0-inf of MWX401.

Time frame
Up to 48 hours post-dose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Minwei Biotechnology Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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