Clinical trial NCT05884242: A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
Official title: Intervention Specific Appendix to PLATFORMPBNAP1001: Evaluation of The Effect of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: From baseline up to Day 14
Secondary outcomes:
measure: Change From Baseline Tumour Necrosis Factor-alpha (TNF-alpha)
timeFrame: From baseline up to Day 14
measure: Longitudinal Change From Baseline in Temperature
timeFrame: From baseline up to Day 14
measure: Longitudinal Change From Baseline in Heart Rate
timeFrame: From baseline up to Day 14
measure: Longitudinal Change From Baseline in Blood Pressure
timeFrame: From baseline up to Day 14
measure: Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to Day 21 (end of study)
measure: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
timeFrame: Up to Day 21 (end of study)
Other outcomes:
Locations:
city: Merksem
country: Belgium
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: