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

NCT07612020 | Recruiting Phase 1

• 1 other identifier: ARGX-117-900-XIND-1003
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• 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

  Up to 33 weeks

• 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

  Up to 33 weeks

• Ctrough at week 8

  Ctrough = trough concentration

  Up to 8 weeks

Secondary Outcomes (7)

• empasiprubart Cmax

  Up to 33 weeks

• AUCw4-8 over time

  Up to 39 weeks

• Cavg over time

  Up to 39 weeks

• Ctrough over time

  Up to 39 weeks

• Percentage change from baseline in free C2 and total C2 over time

  Up to 33 weeks (Part A) + up to 39 weeks (Part B)

Study Arms (5)

Open-label treatment period (part A): empasiprubart SC AI (via abdomen)

EXPERIMENTAL

Participants randomized to receive empasiprubart SC AI via abdomen.

Biological: empasiprubart SC AI

Open-label treatment period (part A): empasiprubart SC AI (via thigh)

EXPERIMENTAL

Participants randomized to receive empasiprubart SC AI via thigh.

Biological: empasiprubart SC AI

Open-label treatment period (part A): empasiprubart IV

EXPERIMENTAL

Participants randomized to receive empasiprubart IV.

Biological: empasiprubart IV

Open-label treatment period (part B): empasiprubart SC AI

EXPERIMENTAL

Participants randomized to receive empasiprubart IV and empasiprubart SC AI.

Biological: empasiprubart SC AI; Biological: empasiprubart IV

Open-label treatment period (part B): empasiprubart IV

EXPERIMENTAL

Participants randomized to receive empasiprubart IV.

Biological: empasiprubart IV

Interventions

empasiprubart SC AI BIOLOGICAL

Subcutaneous injection of empasiprubart via Autoinjector (AI).

Open-label treatment period (part A): empasiprubart SC AI (via abdomen); Open-label treatment period (part A): empasiprubart SC AI (via thigh); Open-label treatment period (part B): empasiprubart SC AI

empasiprubart IV BIOLOGICAL

Intravenous infusion of empasiprubart

Open-label treatment period (part A): empasiprubart IV; Open-label treatment period (part B): empasiprubart IV; Open-label treatment period (part B): empasiprubart SC AI

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• argenx: lead

Study Sites (1)

Altasciences

Mount Royal, Quebec, H3P 3P1, Canada

RECRUITING

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 28, 2026

Record last verified: 2026-05

Locations

CA (1)