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

argenx

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Biological: empasiprubart IV; Biological: empasiprubart SC AI

Study type: Interventional

Funder types: Industry

Identifiers

NCT07612020

ARGX-117-900-XIND-1003

Details and patient eligibility

About

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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130 participants in 5 patient groups

Open-label treatment period (part A): empasiprubart SC AI (via abdomen)

Experimental group

Description:

Participants randomized to receive empasiprubart SC AI via abdomen.

Treatment:

Biological: empasiprubart SC AI

Open-label treatment period (part A): empasiprubart SC AI (via thigh)

Experimental group

Description:

Participants randomized to receive empasiprubart SC AI via thigh.

Treatment:

Biological: empasiprubart SC AI

Open-label treatment period (part A): empasiprubart IV

Experimental group

Description:

Participants randomized to receive empasiprubart IV.

Treatment:

Biological: empasiprubart IV

Open-label treatment period (part B): empasiprubart SC AI

Experimental group

Description:

Participants randomized to receive empasiprubart IV and empasiprubart SC AI.

Treatment:

Biological: empasiprubart IV

Biological: empasiprubart SC AI

Open-label treatment period (part B): empasiprubart IV

Experimental group

Description:

Participants randomized to receive empasiprubart IV.

Treatment:

Biological: empasiprubart IV