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Recruiting 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

Phase I Interventional Healthy Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: empasiprubart SC AI, empasiprubart IV.
Who it may be relevant to
Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

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

Primary outcome measures

  • aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV [Time frame: Up to 33 weeks]
  • aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV [Time frame: Up to 33 weeks]
  • Ctrough at week 8 [Time frame: Up to 8 weeks]
Secondary outcome measures (7)
  • empasiprubart Cmax [Time frame: Up to 33 weeks]
  • AUCw4-8 over time [Time frame: Up to 39 weeks]
  • Cavg over time [Time frame: Up to 39 weeks]
  • Ctrough over time [Time frame: 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)]
  • Incidence of ADA against empasiprubart in serum [Time frame: 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Altasciences — Mount Royal

Identifiers

NCT: NCT07612020 · ARGX-117-900-XIND-1003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗