Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARGX-124 · 1 trial · 1 indication
AE : adverse event ; SAE : serious adverse event.
| Arm | Type | Description |
|---|---|---|
| ARGX-124 | EXPERIMENTAL | Participants receiving the experimental drug |
| Placebo | PLACEBO_COMPARATOR | Participants receiving placebo |
| Name | Type | Description |
|---|---|---|
| ARGX-124 | BIOLOGICAL | Administrations of ARGX-124 |
| Placebo | OTHER | Administrations of placebo comparator |
Inclusion Criteria: * Is at least the local legal age of consent and aged 18 to 65 years, inclusive, when signing the ICF. * Is a female of Nonchildbearing Potential (postmenopausal or surgically sterilized) or a male. * Has a body weight between 50 and 120 kg and a BMI between 18 and 30.5 kg/m2, i...
ARGX-124 is an investigational monoclonal antibody being developed by argenx SE. It is in Phase 1 clinical development and is currently being studied in healthy adult volunteers. The specific diseases or conditions it may eventually treat have not been disclosed.
ARGX-124 targets FcRn, the neonatal Fc receptor. FcRn is a protein that recycles immunoglobulin G antibodies and extends their circulation time in the body. By binding FcRn, ARGX-124 is designed to interact with this recycling pathway, which is the mechanism argenx is evaluating in early clinical testing.
ARGX-124 is being developed by argenx SE, a biotechnology company that trades under the ticker symbol ARGX. Argenx is the sponsor of the clinical program evaluating ARGX-124 and holds the asset within its pipeline of FcRn-directed antibody candidates.
ARGX-124 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The Phase 1 program is designed to assess safety in healthy volunteers before any later-stage studies in patients.
ARGX-124 is being evaluated in one clinical trial, NCT07377396, titled A Study to Assess the Safety of ARGX-124 in Healthy Volunteers. The trial is a Phase 1, randomized, double-blind, placebo-controlled study recruiting 104 healthy adult participants in Canada.
Yes. The ongoing Phase 1 trial of ARGX-124, NCT07377396, enrolls healthy volunteers rather than patients. It is a randomized, double-blind, placebo-controlled study of 104 participants aged 18 years and older, including all sexes, and it is currently recruiting in Canada.