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Also known as Efgartigimod PH20 SC via PFS
Efgartigimod PH20 via PFS · 1 trial · 2 indications
Cmax = maximum observed concentration
AUC0-inf = area under the curve from time 0 to infinity
| Arm | Type | Description |
|---|---|---|
| Treatment sequence 1 | EXPERIMENTAL | Participants randomized to receive Efgartigimod PH20 SC via AI in period 1 and Efgartigimod PH20 SC via PFS in period 2 |
| Treatment sequence 2 | EXPERIMENTAL | Participants randomized to receive Efgartigimod PH20 SC via PFS in period 1 and Efgartigimod PH20 SC via AI in period 2 |
| Name | Type | Description |
|---|---|---|
| Efgartigimod PH20 SC via PFS | BIOLOGICAL | Subcutaneous injection of empasiprubart via Prefilled syringe (PFS) |
| Efgartigimod PH20 SC via AI | BIOLOGICAL | Subcutaneous injection of empasiprubart via Autoinjector (AI) |
Inclusion Criteria: * Is at least the local legal age of consent and aged 18 to 55 years, inclusive, when signing the ICF. * Has a body weight between 50 and 100 kg and a BMI between 18 and 30 kg/m2, inclusive. Exclusion Criteria: * Has any current or past clinically meaningful medical or psychia...
Efgartigimod PH20 via PFS is an investigational monoclonal antibody being developed by argenx SE for use in healthy volunteers. It is currently in Phase 1 clinical development, with one active trial recruiting participants. The drug is administered via a prefilled syringe formulation.
Efgartigimod PH20 via PFS is being studied in healthy adult participants as part of a Phase 1 clinical trial. The trial aims to assess the bioequivalence of the drug when delivered via an autoinjector compared to a prefilled syringe. It is not yet approved for any medical condition.
Efgartigimod PH20 via PFS is developed by argenx SE, a biopharmaceutical company listed on the stock exchange under the ticker ARGX. The company is conducting a Phase 1 clinical trial to evaluate the drug's bioequivalence in healthy volunteers.
Efgartigimod PH20 via PFS is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing trial is recruiting participants to study the drug's bioequivalence in healthy adults.
Efgartigimod PH20 via PFS is being studied in one active Phase 1 clinical trial, identified as NCT07782775. This trial is recruiting 32 healthy adult participants in Canada to assess the bioequivalence of the drug between an autoinjector and a prefilled syringe.
Yes, Efgartigimod PH20 via PFS is also known as Efgartigimod PH20 SC via PFS. Both names refer to the same investigational monoclonal antibody developed by argenx SE, currently in Phase 1 clinical trials for healthy volunteers.