A Study to Assess the Bioequivalence of Efgartigimod PH20 SC Between Autoinjector and Prefilled Syringe in Healthy Adult Participants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
Sponsorargenx
About this trial
The aim of this study is to compare the amount of efgartigimod in the blood over time after it is injected via Prefilled syringe (PFS) and Autoinjector (AI).
The study will comprise 2 study periods of 3 weeks each. Each participant receives both efgartigimod PH20 SC AI and PFS treatments, in a different order.
Participants will be in the study for up to approximately 9 weeks.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF.
Has a body weight between 50 and 100 kg and a BMI between 18 and 30 kg/m2, inclusive.
Disqualifiers
Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
Has received any medications, including nonprescription and prescription medications, within 2 weeks before the first IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
Previously participated in an efgartigimod clinical study and received at least 1 dose of IMP.
Trial design
Design model
Crossover
Treatments tested in this trial
Efgartigimod PH20 SC via PFS
Biological/VaccineSubcutaneous injection of empasiprubart via Prefilled syringe (PFS)
Efgartigimod PH20 SC via AI
Biological/VaccineSubcutaneous injection of empasiprubart via Autoinjector (AI)
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Treatment sequence 1Experimental treatment 2 interventions
Group B: Treatment sequence 2Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Primary PK parameter: Cmax
Cmax = maximum observed concentration
Time frame
Up to 9 weeks2
Primary PK parameter: AUC0-inf
AUC0-inf = area under the curve from time 0 to infinity
Time frame
Up to 9 weeksSecondary outcomes
1
Secondary PK parameter: AUC0-t
AUC0-t = area under the curve from time 0 to the last measurable time point
Time frame
Up to 9 weeks2
Secondary PK parameter: AUC0-168h
AUC0-168h = area under the curve from time 0 to 168 hours
Time frame
Up to 9 weeks3
Secondary PK parameter: CL/F
CL/F = apparent clearance from plasma after extravascular administration
Time frame
Up to 9 weeks4
Secondary PK parameter: Vz/F
Vz/F = apparent volume of distribution at steady state after extravascular administration
Time frame
Up to 9 weeks Source ClinicalTrials.gov