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
21. maj 2026 opdateret af: argenx
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
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
130
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Sabine Coppieters, MD
- Telefonnummer: 857-350-4834
- E-mail: clinicaltrials@argenx.com
Studiesteder
-
-
Quebec
-
Mount Royal, Quebec, Canada, H3P 3P1
- Rekruttering
- Altasciences
-
Kontakt:
- Gaetano Morelli, MD
- Telefonnummer: +1 857-350-4834
- E-mail: clinicaltrials@argenx.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ja
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Open-label treatment period (part A): empasiprubart SC AI (via abdomen)
Participants randomized to receive empasiprubart SC AI via abdomen.
|
Subcutaneous injection of empasiprubart via Autoinjector (AI).
|
|
Eksperimentel: Open-label treatment period (part A): empasiprubart SC AI (via thigh)
Participants randomized to receive empasiprubart SC AI via thigh.
|
Subcutaneous injection of empasiprubart via Autoinjector (AI).
|
|
Eksperimentel: Open-label treatment period (part A): empasiprubart IV
Participants randomized to receive empasiprubart IV.
|
Intravenous infusion of empasiprubart
|
|
Eksperimentel: Open-label treatment period (part B): empasiprubart SC AI
Participants randomized to receive empasiprubart IV and empasiprubart SC AI.
|
Subcutaneous injection of empasiprubart via Autoinjector (AI).
Intravenous infusion of empasiprubart
|
|
Eksperimentel: Open-label treatment period (part B): empasiprubart IV
Participants randomized to receive empasiprubart IV.
|
Intravenous infusion of empasiprubart
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
aBA via abdomen as assessed by AUC0-inf SC versus AUC0-inf IV
Tidsramme: 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
|
Up to 33 weeks
|
|
aBA via thigh as assessed by AUC0-inf SC versus AUC0-inf IV
Tidsramme: 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
|
Up to 33 weeks
|
|
Ctrough at week 8
Tidsramme: Up to 8 weeks
|
Ctrough = trough concentration
|
Up to 8 weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
empasiprubart Cmax
Tidsramme: Up to 33 weeks
|
Cmax = maximum observed concentration
|
Up to 33 weeks
|
|
AUCw4-8 over time
Tidsramme: Up to 39 weeks
|
AUCw4-8 = area under the concentration-time curve from week 4 to week 8
|
Up to 39 weeks
|
|
Cavg over time
Tidsramme: Up to 39 weeks
|
Cavg = average concentration
|
Up to 39 weeks
|
|
Ctrough over time
Tidsramme: Up to 39 weeks
|
Ctrough = trough concentration
|
Up to 39 weeks
|
|
Percentage change from baseline in free C2 and total C2 over time
Tidsramme: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
C2 = complement component 2
|
Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
|
Incidence of ADA against empasiprubart in serum
Tidsramme: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
ADA = antidrug antibody(ies)
|
Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
|
Incidence of AEs, SAEs, and AEs leading to empasiprubart discontinuation
Tidsramme: Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
AE=adverse event; SAE=serious adverse event
|
Up to 33 weeks (Part A) + up to 39 weeks (Part B)
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
16. marts 2026
Primær færdiggørelse (Anslået)
1. marts 2027
Studieafslutning (Anslået)
1. oktober 2027
Datoer for studieregistrering
Først indsendt
21. maj 2026
Først indsendt, der opfyldte QC-kriterier
21. maj 2026
Først opslået (Faktiske)
28. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ARGX-117-900-XIND-1003
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