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

Sponsor
argenx
Study ID
NCT07612020
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • empasiprubart SC AI — BIOLOGICAL
    Subcutaneous injection of empasiprubart via Autoinjector (AI).
  • empasiprubart IV — BIOLOGICAL
    Intravenous infusion of empasiprubart

Study Details

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.

Key Dates

Start date
Mar 16, 2026
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Open-label treatment period (part A): empasiprubart SC AI (via abdomen)
    Participants randomized to receive empasiprubart SC AI via abdomen.
  • Experimental: Open-label treatment period (part A): empasiprubart SC AI (via thigh)
    Participants randomized to receive empasiprubart SC AI via thigh.
  • Experimental: Open-label treatment period (part A): empasiprubart IV
    Participants randomized to receive empasiprubart IV.
  • Experimental: Open-label treatment period (part B): empasiprubart SC AI
    Participants randomized to receive empasiprubart IV and empasiprubart SC AI.
  • Experimental: Open-label treatment period (part B): empasiprubart IV
    Participants randomized to receive empasiprubart IV.

Primary Outcome Measure

aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV [ Time Frame: Up to 33 weeks ]

Central Contacts

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