Empasiprubart: how your body handles an autoinjector shot versus IV in healthy adults
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
Run by argenx · NCT07612020 · Data updated 2026-11-12
This study tests how empasiprubart behaves in the body when given as a subcutaneous autoinjector injections in the abdomen or thigh compared with IV, in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | argenx Industry-sponsored |
| Locations | 1 site (Mount Royal, Quebec) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | March 2027 |
| Study ends | October 2027 |
| Registry record updated | May 28, 2026 |
| Trial ID | NCT07612020 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with body weight 50–120 kg and BMI 18–35 kg/m2 who are healthy and without major illnesses.
✕Probably not a fit
Participants with certain autoimmune diseases or immune conditions, or those with a history of SLE, may not derive benefit and could be at higher risk from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase study has two parts to compare how empasiprubart is absorbed and processed when given subcutaneously via an autoinjector versus intravenously. Part A randomizes healthy volunteers to receive SC autoinjector injections in the abdomen or thigh or IV infusion, then Part B randomizes to SC abdomen or IV. The trial aims to characterize absolute bioavailability, pharmacokinetics, safety, and tolerability. Participants stay in the study for up to about 37 weeks in Part A and up to about 43 weeks in Part B. The study is sponsored by argenx and conducted at Altasciences in Mount Royal, Quebec.
Why it matters
Potential benefit: If successful, the results could guide dosing and administration choices for empasiprubart to optimize exposure and safety.
How similar studies have gone: Previous studies of similar subcutaneous versus IV administration approaches have shown measurable differences in pharmacokinetics but this study is an early-phase evaluation in healthy volunteers.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Altasciences
Mount Royal, Quebec, Canada Recruiting
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: clinicaltrials@argenx.com
- Phone: 857-350-4834
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.