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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05884242 | A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge | PHASE1 | COMPLETED | 20 | — | — | May 22, 2023 | Aug 7, 2023 | Mar 30, 2025 | 1 | Belgium |
Change from the baseline in CRP levels will be reported.
| Arm | Type | Description |
|---|---|---|
| Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge | EXPERIMENTAL | Healthy participants will receive adalimumab subcutaneous (SC) injections via prefilled syringe or prefilled pen on Day 1, followed by the LPS intravenous (IV) injection challenge on Day 6. |
| Control Arm: LPS Challenge | EXPERIMENTAL | Participants will receive LPS IV injection on Day 6. No study interaction will be administered. |
| Name | Type | Description |
|---|---|---|
| Adalimumab | DRUG | Adalimumab will be administered subcutaneously. |
| Lipopolysaccharide (LPS) | DRUG | LPS will be administered intravenously. |
Inclusion Criteria: * A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 5 months after adalimumab administration * A female participant must agree not to be pregnant or planning to become pregnant while e...