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A Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus Intravenous (IV) in Healthy Adult Participants

ConditionHealthy Volunteers
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
Sponsorargenx

About this trial

This study aims to see how the body reacts to empasiprubart, administered using an autoinjector (AI). The study will also look at other effects of empasiprubart, how it works in the body, and if it is safe.

The study consists of 2 parts: parts A and B. In part A, eligible participants will be randomized to receive empasiprubart SC AI via abdomen, empasiprubart SC AI via thigh, or empasiprubart IV (intravenously). In part B, eligible participants will be randomized to receive empasiprubart SC AI via abdomen or empasiprubart IV.

Participants from part A will be in the study for approximately up to 37 weeks . Participants from part B will be in the study for up to approximately 43 weeks.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF.

Has a body weight between 50 and 120 kg and a BMI between 18 and 35 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.

Clinical diagnosis of SLE. For participants with an antinuclear antibody titer of ≥1:80 and a positive anti-double-stranded DNA and/or positive anti-Smith result at screening, an SLE diagnosis must be ruled out before the first IMP administration.

Previously participated in an empasiprubart clinical study and received at least 1 dose of IMP.

Trial design

Design model

Parallel

Treatments tested in this trial

  • empasiprubart SC AI

    Biological/Vaccine

    Subcutaneous injection of empasiprubart via Autoinjector (AI).

  • empasiprubart IV

    Biological/Vaccine

    Intravenous infusion of empasiprubart

Treatment groups

130 Participants
are divided into 5 treatment groups
Group A: Open-label treatment period (part A): empasiprubart SC AI (via abdomen)Experimental treatment 1 intervention
Group B: Open-label treatment period (part A): empasiprubart SC AI (via thigh)Experimental treatment 1 intervention
Group C: Open-label treatment period (part A): empasiprubart IVExperimental treatment 1 intervention
Group D: Open-label treatment period (part B): empasiprubart SC AIExperimental treatment 2 interventions
Group E: Open-label treatment period (part B): empasiprubart IVExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV

aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous

Time frame
Up to 33 weeks
2

aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV

aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous

Time frame
Up to 33 weeks
3

Ctrough at week 8

Ctrough = trough concentration

Time frame
Up to 8 weeks

Secondary outcomes

1

empasiprubart Cmax

Cmax = maximum observed concentration

Time frame
Up to 33 weeks
2

AUCw4-8 over time

AUCw4-8 = area under the concentration-time curve from week 4 to week 8

Time frame
Up to 39 weeks
3

Cavg over time

Cavg = average concentration

Time frame
Up to 39 weeks
4

Ctrough over time

Ctrough = trough concentration

Time frame
Up to 39 weeks

Other outcomes

Sponsors and contacts

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

argenx

Lead sponsor

Source ClinicalTrials.gov
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