Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARGX-109 · 1 trial · 1 indication
AE: adverse event, SAE: serious adverse event
| Arm | Type | Description |
|---|---|---|
| ARGX-109 | EXPERIMENTAL | Participants receiving the experimental drug |
| Placebo | PLACEBO_COMPARATOR | Participants receiving placebo |
| Name | Type | Description |
|---|---|---|
| ARGX-109 | BIOLOGICAL | administrations of ARGX-109 |
| Placebo | OTHER | administrations of placebo comparator |
Inclusion Criteria: * is aged 18 to 65 years, inclusive, when signing the ICF * has a body weight between 50 and 100 kg and a BMI between 18.5 and 30.0 kg/m2, inclusive Exclusion Criteria: * Has any current or past clinically meaningful medical or psychiatric condition that, in the investigator's...
ARGX-109 is an investigational monoclonal antibody being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial assessing its safety in this population. The drug is not approved for any indication and remains under investigation.
ARGX-109 is being developed by argenx SE, a biopharmaceutical company traded on the stock exchange under the ticker ARGX. The company is conducting clinical trials to evaluate the safety of this investigational monoclonal antibody in healthy volunteers.
ARGX-109 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the drug remains investigational. It has not been approved by regulatory authorities and is still undergoing clinical evaluation for safety in healthy volunteers.
ARGX-109 has one completed clinical trial, identified as NCT06799416, titled "A Study to Assess the Safety of ARGX-109 in Healthy Volunteers." This Phase 1, randomized, double-blind, placebo-controlled study enrolled 40 participants in Canada and included healthy volunteers aged 18 years and older.
ARGX-109 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A completed trial has assessed its safety in healthy volunteers, but the drug has not received regulatory approval for any use.