A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge

NCT ID: NCT05884242

Last Updated: 2025-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-22
• Study Completion Date: 2023-08-07

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge

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.

Group Type: EXPERIMENTAL

Adalimumab

Intervention Type: DRUG

Adalimumab will be administered subcutaneously.

Lipopolysaccharide (LPS)

Intervention Type: DRUG

LPS will be administered intravenously.

Control Arm: LPS Challenge

Participants will receive LPS IV injection on Day 6. No study interaction will be administered.

Group Type: EXPERIMENTAL

Lipopolysaccharide (LPS)

Intervention Type: DRUG

LPS will be administered intravenously.

Interventions

Adalimumab

Adalimumab will be administered subcutaneously.

Intervention Type: DRUG

Lipopolysaccharide (LPS)

LPS will be administered intravenously.

Intervention Type: DRUG

Other Intervention Names

Humira

Eligibility Criteria

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 enrolled in this study or within 5 months after the last dose of adalimumab
• Must agree not to receive any vaccinations (including those authorized for emergency use, for example, Coronavirus disease-19 (COVID-19) within 2 weeks after study intervention administration
• A male participant must agree not to plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention
• Has a negative severe acute respiratory syndrome coronavirus 2 (COVID-19) reverse transcription-polymerase chain reaction test within 72 hours prior to adalimumab administration on Day 1
• Otherwise healthy on the basis of physical examination, medical history, and vital signs, and 12-lead electrocardiogram (ECG) performed at screening. Any abnormalities must be considered not clinically significant or consistent with the underlying illness in the study population, as specified in the applicable intervention specific appendix (ISA), and this determination must be recorded in the participant's source documents and initiated by the investigator
• Otherwise healthy on the basis of clinical laboratory tests performed at screening. If the results of the serum chemistry panel, blood coagulation, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study. This determination must be recorded in the participant's source documents and initiated by the investigator

Exclusion Criteria

• Has a history of congestive heart failure or chronic obstructive pulmonary disease
• Has a history of central or peripheral nervous system demyelinating disease (for example, multiple sclerosis, optic neuritis, or including Guillain-Barre syndrome, respectively)
• Has surgery planned within 10 weeks after the study intervention administration
• Known allergies, hypersensitivity, or intolerance to adalimumab or its excipients
• Had major illness or surgery, (for example, requiring general anesthesia) within 24 weeks before screening, or will not have fully recovered from illness or surgery, or has surgery planned during the time the participant is expected to participate in the study and up to 10 weeks after administration of the study intervention
• History of liver or renal insufficiency significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances, unless consistent with the underlying disease of interest in the study population, if applicable
• History of any type of immunodeficiency or autoimmune disease or disease treatment associated with immune suppression or lymphopenia, unless consistent with the underlying disease of interest in the study population, if applicable. These include but are not limited to bone marrow or organ transplantation, lymphoproliferative disorders, T- or B-cell deficiency syndromes, splenectomy, functional asplenia and chronic granulomatous disease
• Has an active, acute, or chronic infection

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Clinical Pharmacology Unit

Merksem, , Belgium

Countries

Belgium

Other Identifiers

2022-002896-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NOPRODPBNAP1001

Identifier Type: OTHER

Identifier Source: secondary_id

PLATFORMPBNAP1001

Identifier Type: OTHER

Identifier Source: secondary_id

CR109299

Identifier Type: -

Identifier Source: org_study_id