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
| NCT ID | NCT07612020 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | argenx |
| Condition | Healthy Volunteers |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 130 participants in total. It began in 2026-03-16 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07612020 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Volunteers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07612020 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07612020 currently recruiting?
Yes, NCT07612020 is actively recruiting participants. Contact the research team at clinicaltrials@argenx.com for enrollment information.
Where is the NCT07612020 trial being conducted?
This trial is being conducted at Mount Royal, Canada.
Who is sponsoring the NCT07612020 clinical trial?
NCT07612020 is sponsored by argenx. The trial plans to enroll 130 participants.