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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-002896-13 | EudraCT Number | ||
| NOPRODPBNAP1001 | Other Identifier | Janssen Research & Development, LLC | |
| PLATFORMPBNAP1001 | Other Identifier | Janssen Research & Development, LLC |
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The purpose of the study is to characterize the inflammatory response to lipopolysaccharide (LPS; molecules that contains fats and carbohydrates) in the presence of a targeted immune pathway modulator.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Adalimumab will be administered subcutaneously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in C-reactive Protein (CRP) | Change from the baseline in CRP levels will be reported. | From baseline up to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Tumour Necrosis Factor-alpha (TNF-alpha) | Change from baseline in TNF-alpha levels will be reported. | From baseline up to Day 14 |
| Longitudinal Change From Baseline in Temperature |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| D008070 | Lipopolysaccharides |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Lipopolysaccharide (LPS) | Drug | LPS will be administered intravenously. |
|
Longitudinal change from baseline in temperature [skin] will be reported.
| From baseline up to Day 14 |
| Longitudinal Change From Baseline in Heart Rate | Longitudinal change from baseline in heart rate will be reported. | From baseline up to Day 14 |
| Longitudinal Change From Baseline in Blood Pressure | Longitudinal change from baseline in blood pressure will be reported. | From baseline up to Day 14 |
| Percentage of Participants with Treatment-emergent Adverse Events (TEAEs) | Percentage of participants with TEAEs through Day 14 will be reported. An adverse event (AE) is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the intervention under study. TEAEs are defined as AEs with onset or worsening on or after date of first dose of study treatment. | Up to Day 21 (end of study) |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) | Percentage of participants with treatment-emergent SAEs will be reported. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly. Treatment-emergent SAEs are defined as serious events between administration of study drug and after the last dose that were absent before treatment or that worsen relative to pretreatment state. | Up to Day 21 (end of study) |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D008055 | Lipids |
| D000942 | Antigens, Bacterial |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D004731 | Endotoxins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |