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

May 21, 2026 updated by: argenx

A Phase 1, Randomized, Open-Label Study to Assess the Absolute Bioavailability of Empasiprubart SC Administered With an Autoinjector (Part A) and the Pharmacokinetic Noninferiority of Empasiprubart SC Versus IV (Part B) in Healthy Adult Participants

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

130

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Quebec
      • Mount Royal, Quebec, Canada, H3P 3P1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open-label treatment period (part A): empasiprubart SC AI (via abdomen)
Participants randomized to receive empasiprubart SC AI via abdomen.
Biological: empasiprubart SC AI
Subcutaneous injection of empasiprubart via Autoinjector (AI).
Experimental: Open-label treatment period (part A): empasiprubart SC AI (via thigh)
Participants randomized to receive empasiprubart SC AI via thigh.
Biological: empasiprubart SC AI
Subcutaneous injection of empasiprubart via Autoinjector (AI).
Experimental: Open-label treatment period (part A): empasiprubart IV
Participants randomized to receive empasiprubart IV.
Biological: empasiprubart IV
Intravenous infusion of empasiprubart
Experimental: Open-label treatment period (part B): empasiprubart SC AI
Participants randomized to receive empasiprubart IV and empasiprubart SC AI.
Biological: empasiprubart SC AI
Subcutaneous injection of empasiprubart via Autoinjector (AI).
Biological: empasiprubart IV
Intravenous infusion of empasiprubart
Experimental: Open-label treatment period (part B): empasiprubart IV
Participants randomized to receive empasiprubart IV.
Biological: empasiprubart IV
Intravenous infusion of empasiprubart

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV
Time Frame: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Up to 33 weeks
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV
Time Frame: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Up to 33 weeks
Ctrough at week 8
Time Frame: Up to 8 weeks
Ctrough = trough concentration
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
empasiprubart Cmax
Time Frame: Up to 33 weeks
Cmax = maximum observed concentration
Up to 33 weeks
AUCw4-8 over time
Time Frame: Up to 39 weeks
AUCw4-8 = area under the concentration-time curve from week 4 to week 8
Up to 39 weeks
Cavg over time
Time Frame: Up to 39 weeks
Cavg = average concentration
Up to 39 weeks
Ctrough over time
Time Frame: Up to 39 weeks
Ctrough = trough concentration
Up to 39 weeks
Percentage change from baseline in free C2 and total C2 over time
Time Frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
C2 = complement component 2
Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of ADA against empasiprubart in serum
Time Frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
ADA = antidrug antibody(ies)
Up to 33 weeks (Part A) + up to 39 weeks (Part B)
Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation
Time Frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
AE=adverse event; SAE=serious adverse event
Up to 33 weeks (Part A) + up to 39 weeks (Part B)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

argenx

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 21, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • ARGX-117-900-XIND-1003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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