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

NCT05884242 | Completed Phase 1 FDA Drug

• 4 other identifiers: CR1092992022-002896-13NOPRODPBNAP1001PLATFORMPBNAP1001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in C-reactive Protein (CRP)

  Change from the baseline in CRP levels will be reported.

  From baseline up to Day 14

Secondary Outcomes (6)

• Change From Baseline Tumour Necrosis Factor-alpha (TNF-alpha)

  From baseline up to Day 14

• Longitudinal Change From Baseline in Temperature

  From baseline up to Day 14

• Longitudinal Change From Baseline in Heart Rate

  From baseline up to Day 14

• Longitudinal Change From Baseline in Blood Pressure

  From baseline up to Day 14

• Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)

  Up to Day 21 (end of study)

Study Arms (2)

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.

Drug: Adalimumab; Drug: Lipopolysaccharide (LPS)

Control Arm: LPS Challenge

EXPERIMENTAL

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

Drug: Lipopolysaccharide (LPS)

Interventions

Adalimumab DRUG

Adalimumab will be administered subcutaneously.

Also known as: Humira

Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge

Lipopolysaccharide (LPS) DRUG

LPS will be administered intravenously.

Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge; Control Arm: LPS Challenge

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Clinical Pharmacology Unit

Merksem, 2170, Belgium

Location

MeSH Terms

Interventions

Adalimumab; Lipopolysaccharides

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Glycoconjugates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides; Lipids; Antigens, Bacterial; Antigens; Biological Factors; Endotoxins; Bacterial Toxins; Toxins, Biological

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: May 22, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 7, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)