Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Lipopolysaccharide · 1 trial · 1 indication
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...
Lipopolysaccharide is an investigational small molecule being studied in healthy volunteers as part of a clinical trial. It is used as a challenge agent to induce a systemic inflammatory response, allowing researchers to evaluate the effects of other drugs, such as adalimumab, on inflammatory mediators. It is not intended for therapeutic use in patients.
Lipopolysaccharide is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker symbol JNJ. The company is conducting research on this compound in a Phase 1 clinical trial setting.
Lipopolysaccharide is in Phase 1 clinical development. It has completed one Phase 1 trial, which was a controlled study involving 20 healthy volunteers. The compound is investigational and has not been approved for any medical use.
Lipopolysaccharide has been studied in one completed clinical trial, identified as NCT05884242. This trial, titled 'A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge,' was a Phase 1 study conducted in Belgium with 20 healthy participants aged 18 years and older.
Lipopolysaccharide is commonly known as endotoxin, a component of the outer membrane of Gram-negative bacteria. In the clinical trial context, it is used to trigger a controlled inflammatory response in healthy volunteers to study the effects of other medications on immune system mediators.