- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07673601
A Study to Assess the Absolute Bioavailability and How Adimanebart SC Moves Through the Body in Healthy Adult Participants
A Phase 1, Open-Label, Randomized, Single Dose, Parallel-Group Study to Assess the Absolute Bioavailability and Evaluate the Effect of Body Weight on the Pharmacokinetics of Adimanebart SC in Healthy Adult Participants
This study aims to find out how much adimanebart gets into the blood circulation of healthy adults. Researchers will measure the amount of adimanebart in blood over time to learn how it moves through the body. The drug's safety will also be assessed.
The participants will be assigned to one of 3 parts of the study: part 1 investigates the absolute bioavailability; part 2 investigates the effect of different body weights on adimanebart in blood after subcutaneous (SC) dosing; part 3 investigates formulation adaptations.
Participants will be in the study for approximately up to 24 weeks.
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Sabine Coppieters, MD
- Telefonnummer: 857-350-4834
- E-post: clinicaltrials@argenx.com
Studieorter
-
-
-
Montreal, Kanada, H3P 3P1
- Rekrytering
- Altasciences
-
Kontakt:
- Gaetano Morelli, MD
- Telefonnummer: 857-350-4834
- E-post: clinicaltrials@argenx.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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 60 and 100 kg and a BMI between 18.5 and 30 kg/m2, inclusive, at screening and on day -1 for part 1 and part 3, or has a body weight <60 kg or between 100 and 130 kg and a BMI between 18.5 and 38.0 kg/m2, inclusive, at screening and on day -1 for part 2.
- Discontinues and refrains from using all medications, including nonprescription and prescription medications, for ≥2 weeks before IMP administration, except for hormonal contraceptives and hormone replacement therapy in female participants. The occasional use of acetaminophen or ibuprofen is allowed.
Exclusion Criteria:
- Has any current or past clinically meaningful medical or psychiatric condition, including severe hypersensitivity reactions to drugs and/or food that, in the investigator's opinion, would confound the study results or put the participant at undue risk.
- Previously participated in an adimanebart clinical study and received at least 1 dose of IMP.
- Is currently participating in another interventional clinical study, or has received an IMP in another clinical study within 12 weeks or 5 half-lives (whichever is longer) before screening.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Part 1 - Adimanebart IV
Participants randomized to receive adimanebart IV
|
Intravenous infusion of adimanebart IV
|
|
Experimentell: Part 1 - Adimanebart SC (formulation A)
Participants randomized to receive adimanebart SC
|
Subcutaneous administration of Adminanebart SC
|
|
Experimentell: Part 2 - Adimanebart SC (formulation A) in lower body weights
Participants with body weight < 60 kg will receive adimanebart SC
|
Subcutaneous administration of Adminanebart SC
|
|
Experimentell: Part 2 - Adimanebart SC (formulation A) in higher body weights
Participants with body weight between 100 and 130 kg will receive adimanebart SC
|
Subcutaneous administration of Adminanebart SC
|
|
Experimentell: Part 3 - Adimanebart SC (formulation B)
Participants randomized to receive adimanebart SC formulation B
|
Subcutaneous administration of Adminanebart SC
|
|
Experimentell: Part 3 - Adimanebart SC (formulation C)
Participants randomized to receive adimanebart SC formulation C
|
Subcutaneous administration of Adminanebart SC
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
AUC0-inf
Tidsram: Up to 20 weeks
|
AUC0-inf = area under the concentration-time curve from time 0 to infinity
|
Up to 20 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
adimanebart SC PK parameter: Cmax
Tidsram: Up to 20 weeks
|
Cmax = maximum observed concentration
|
Up to 20 weeks
|
|
Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation
Tidsram: Up to 20 weeks
|
AE = adverse event ; SAE = serious adverse event
|
Up to 20 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- ARGX-119-900-XIND-1002
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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