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NCT Number: NCT07612020

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

empasiprubart SC AI

Biological

Subcutaneous injection of empasiprubart via Autoinjector (AI).

Empasiprubart IV

Biological

Intravenous infusion of empasiprubart

Primary outcomes

  1. 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

  2. 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

  3. Ctrough at week 8

    Time frame: Up to 8 weeks

    Ctrough = trough concentration

Secondary outcomes

  1. empasiprubart Cmax

    Time frame: Up to 33 weeks

    Cmax = maximum observed concentration

  2. AUCw4-8 over time

    Time frame: Up to 39 weeks

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

  3. Cavg over time

    Time frame: Up to 39 weeks

    Cavg = average concentration

  4. Ctrough over time

    Time frame: Up to 39 weeks

    Ctrough = trough concentration

  5. 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

  6. 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)

  7. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Coppieters, MD

CONTACT

[email protected]

857-350-4834

Sponsors and collaborators

Lead sponsor

argenx

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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