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
Recruiting
Phase 1
Interventional Study
Healthy Volunteers
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 130 (estimated)
- Sponsor
- argenx · Industry
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About This Trial
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…
Trial Locations
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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 psychia…
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