NCT07818291
An Open-label, Dose-escalation Phase Ib Study of EA5 Injection in Adults With Anti-AChR Antibody-Positive Generalized Myasthenia Gravis
StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History
All 1 version: 1 with changes below.
- Study First Submitted
Endpoints
Primary
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Timeframe: Baseline up to Week 14
Secondary (23)
Change and percentage change from baseline in MG-ADL total score.
Change and percentage change from baseline in QMG total score.
Change and percentage change from baseline in MGC total score.
Change and percentage change from baseline in MG-QoL15r scale.
Proportion of participants achieving MG-ADL response without rescue therapy.
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Proportion of participants achieving an improvement of 4, 5, 6, 7, and ≥8 points from baseline in QMG total score without rescue therapy.
Maximum Observed Serum Concentration (Cmax) of EA5
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) of EA5
Minimum Steady-State Concentration (Cmin,ss) of EA5
Maximum Steady-State Concentration (Cmax,ss) of EA5
Average Steady-State Concentration (Cav.ss) of EA5
Steady-State Trough Concentration (Ctrough,ss) of EA5
Time to Maximum Steady-State Concentration (Tmax,ss) of EA5
Area Under the Concentration-Time Curve over One Dosing Interval at Steady State (AUC0-τ) of EA5
Degree of Fluctuation of EA5
Serum total complement hemolytic activity (CH50
Serum total C5 concentration
Serum free C5 concentration
Concentrations of plasma soluble C5b-9 (sC5b-9)
Anti-acetylcholine receptor antibody (AChR-Ab) titer
Incidence of anti-drug antibodies (ADA) against the humanized monoclonal antibody EA5
Incidence of Incidence of neutralizing antibodies (NAb) against the humanized monoclonal antibody EA5
Arms and interventions
Administration of low-dose EA5Experimental
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
Administration of mid-dose EA5Experimental
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 2 weeks(Q2W).
Administration of high-dose EA5Experimental
First, administer the loading dose regimen intravenously, then maintain administration subcutaneously every 4 weeks(Q4W).
Drugs: EA5
Sites
2 sites in 1 country