Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as empasiprubart SC AI
empasiprubart AI · 1 trial · 1 indication
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
aBA = absolute bioavailability; AUC0-inf=area under the concentration-time curve from time 0 to infinity; PK = pharmacokinetics; SC = subcutaneous, IV = intravenous
Ctrough = trough concentration
| Arm | Type | Description |
|---|---|---|
| Open-label treatment period (part A): empasiprubart SC AI (via abdomen) | EXPERIMENTAL | Participants randomized to receive empasiprubart SC AI via abdomen. |
| Open-label treatment period (part A): empasiprubart SC AI (via thigh) | EXPERIMENTAL | Participants randomized to receive empasiprubart SC AI via thigh. |
| Open-label treatment period (part A): empasiprubart IV | EXPERIMENTAL | Participants randomized to receive empasiprubart IV. |
| Open-label treatment period (part B): empasiprubart SC AI | EXPERIMENTAL | Participants randomized to receive empasiprubart IV and empasiprubart SC AI. |
| Open-label treatment period (part B): empasiprubart IV | EXPERIMENTAL | Participants randomized to receive empasiprubart IV. |
| Name | Type | Description |
|---|---|---|
| empasiprubart SC AI | BIOLOGICAL | Subcutaneous injection of empasiprubart via Autoinjector (AI). |
| empasiprubart IV | BIOLOGICAL | Intravenous infusion of empasiprubart |
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 psychia...
Empasiprubart AI is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development, with an active trial assessing its absolute bioavailability and pharmacokinetic noninferiority when given subcutaneously with an autoinjector versus intravenously. It is not approved for any condition.
Empasiprubart AI is being developed by argenx SE, a biopharmaceutical company traded on the stock exchange under the ticker ARGX. The company is conducting a Phase 1 clinical trial of the drug in healthy adult participants.
Empasiprubart AI is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants and is designed to evaluate the drug's bioavailability and pharmacokinetics in healthy volunteers.
Empasiprubart AI is being studied in one active Phase 1 clinical trial, registered as NCT07612020. The trial is recruiting 130 healthy adult participants in Canada and is assessing the absolute bioavailability of empasiprubart SC administered with an autoinjector and the pharmacokinetic noninferiority of subcutaneous versus intravenous administration.
Yes, empasiprubart AI is also known as empasiprubart SC AI. The alternative name reflects the subcutaneous route of administration being studied in the ongoing Phase 1 clinical trial, which compares subcutaneous delivery via an autoinjector with intravenous delivery.
In the ongoing Phase 1 trial, empasiprubart AI is administered both subcutaneously, using an autoinjector, and intravenously. The study is designed to compare the absolute bioavailability and pharmacokinetic noninferiority of these two routes of administration in healthy adult participants.