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 1RecruitingNCT07612020

argenx130 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

130

Conditions

Healthy Volunteers

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV

aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous

Time frame: Up to 33 weeks

aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV

aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous

Time frame: Up to 33 weeks

Ctrough at week 8

Ctrough = trough concentration

Time frame: Up to 8 weeks

Secondary Outcomes

empasiprubart Cmax

Cmax = maximum observed concentration

Time frame: Up to 33 weeks

AUCw4-8 over time

AUCw4-8 = area under the concentration-time curve from week 4 to week 8

Time frame: Up to 39 weeks

Cavg over time

Cavg = average concentration

Time frame: Up to 39 weeks

Ctrough over time

Ctrough = trough concentration

Time frame: Up to 39 weeks

Percentage change from baseline in free C2 and total C2 over time

C2 = complement component 2

Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)

Incidence of ADA against empasiprubart in serum

ADA = antidrug antibody(ies)

Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)

Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation

AE=adverse event; SAE=serious adverse event

Time frame: Up to 33 weeks (Part A) + up to 39 weeks (Part B)

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts