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

Janssen (J&J Innovative Medicine)

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Adalimumab

Drug: Lipopolysaccharide (LPS)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05884242

2022-002896-13 (EudraCT Number)

CR109299

PLATFORMPBNAP1001 (Other Identifier)

NOPRODPBNAP1001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

20 participants in 2 patient groups

Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge

Experimental group

Description:

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.

Treatment:

Drug: Lipopolysaccharide (LPS)

Drug: Adalimumab

Control Arm: LPS Challenge

Experimental group

Description:

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

Treatment:

Drug: Lipopolysaccharide (LPS)