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
- 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.
- Short title
- 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
- 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
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2027-10-01
- First posted
- 2026-05-28
- Registry last updated
- 2026-05-28
- Primary completion date
- 2027-03-01
- Start date
- 2026-03-16
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- argenx
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07612020
- ClinicalTrials.gov ID
- NCT07612020
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Single masking
- Masked roles
- Outcome assessors
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV
Timeframe: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV
Timeframe: Up to 33 weeks
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Ctrough at week 8
Timeframe: Up to 8 weeks
Ctrough = trough concentration
empasiprubart Cmax
Timeframe: Up to 33 weeks
Cmax = maximum observed concentration
AUCw4-8 over time
Timeframe: Up to 39 weeks
AUCw4-8 = area under the concentration-time curve from week 4 to week 8
Cavg over time
Timeframe: Up to 39 weeks
Cavg = average concentration
Ctrough over time
Timeframe: Up to 39 weeks
Ctrough = trough concentration
Percentage change from baseline in free C2 and total C2 over time
Timeframe: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
C2 = complement component 2
Incidence of ADA against empasiprubart in serum
Timeframe: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
ADA = antidrug antibody(ies)
Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation
Timeframe: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
AE=adverse event; SAE=serious adverse event
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- AltasciencesMount Royal, CanadaRecruiting