Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 - Adimanebart IV | Experimental | Participants randomized to receive adimanebart IV |
|
| Part 1 - Adimanebart SC (formulation A) | Experimental | Participants randomized to receive adimanebart SC |
|
| Part 2 - Adimanebart SC (formulation A) in lower body weights | Experimental | Participants with body weight < 60 kg will receive adimanebart SC |
|
| Part 2 - Adimanebart SC (formulation A) in higher body weights | Experimental | Participants with body weight between 100 and 130 kg will receive adimanebart SC |
|
| Part 3 - Adimanebart SC (formulation B) | Experimental | Participants randomized to receive adimanebart SC formulation B |
|
| Part 3 - Adimanebart SC (formulation C) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adimanebart IV | Biological | Intravenous infusion of adimanebart IV |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-inf | AUC0-inf = area under the concentration-time curve from time 0 to infinity | Up to 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| adimanebart SC PK parameter: Cmax | Cmax = maximum observed concentration | Up to 20 weeks |
| Incidence of AEs, SAEs, and AEs leading to adimanebart discontinuation | AE = adverse event ; SAE = serious adverse event |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Coppieters, MD | Contact | 857-350-4834 | clinicaltrials@argenx.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altasciences | Recruiting | Montreal | H3P 3P1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Experimental |
Participants randomized to receive adimanebart SC formulation C |
|
| Adimanebart SC - formulation A |
| Biological |
Subcutaneous administration of Adminanebart SC |
|
| Adimanebart SC - formulation B | Biological | Subcutaneous administration of Adminanebart SC |
|
| Adimanebart SC - formulation C | Biological | Subcutaneous administration of Adminanebart SC |
|
| Up to 20 weeks |