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

Healthy Clinical Trial

Official title:

Intervention Specific Appendix to PLATFORMPBNAP1001: Evaluation of The Effect of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05884242
• Other study ID #: CR109299
• Secondary ID: 2022-002896-13NO
• Status: Completed
• Phase: Phase 1
• Start date: May 22, 2023
• Est. completion date: August 7, 2023

Study information

• Verified date: September 2023
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 7, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Adalimumab
Adalimumab will be administered subcutaneously.
• Lipopolysaccharide (LPS)
LPS will be administered intravenously.

Locations

Country	Name	City	State
Belgium	Clinical Pharmacology Unit	Merksem

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Longitudinal Change From Baseline in Temperature	Longitudinal change from baseline in temperature [skin] will be reported.	From baseline up to Day 14
Secondary	Longitudinal Change From Baseline in Heart Rate	Longitudinal change from baseline in heart rate will be reported.	From baseline up to Day 14
Secondary	Longitudinal Change From Baseline in Blood Pressure	Longitudinal change from baseline in blood pressure will be reported.	From baseline up to Day 14
Secondary	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)
Secondary	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)