Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06799416 | A Study to Assess the Safety of ARGX-109 in Healthy Volunteers | PHASE1 | COMPLETED | 40 | — | — | Jan 14, 2025 | Aug 8, 2025 | Sep 18, 2025 | 1 | Canada |
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...