HealthyPhase 1NCT05884242
A Study of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
A Phase 1 study testing Adalimumab and Lipopolysaccharide (LPS) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Adalimumab and Lipopolysaccharide (LPS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 22 May 2023to 7 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Specific Appendix to PLATFORMPBNAP1001: Evaluation of The Effect of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
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
- Being tested
- Adalimumab, Lipopolysaccharide (LPS)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Also called Humira
Adalimumab will be administered subcutaneously.
Lipopolysaccharide (LPS)Drug
LPS will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lipopolysaccharide (LPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in C-reactive Protein (CRP)
Change from the baseline in CRP levels will be reported.
Measured: From baseline up to Day 14
Secondary outcomes (6)
Change From Baseline Tumour Necrosis Factor-alpha (TNF-alpha)
Change from baseline in TNF-alpha levels will be reported.
Measured: From baseline up to Day 14
Longitudinal Change From Baseline in Temperature
Longitudinal change from baseline in temperature [skin] will be reported.
Measured: From baseline up to Day 14
Longitudinal Change From Baseline in Heart Rate
Longitudinal change from baseline in heart rate will be reported.
Measured: From baseline up to Day 14
Longitudinal Change From Baseline in Blood Pressure
Longitudinal change from baseline in blood pressure will be reported.
Measured: From baseline up to Day 14
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.
Measured: Up to Day 21 (end of study)
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.
Measured: Up to Day 21 (end of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start22 May 2023
- Primary completion1 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884242
- Sponsor's protocol ID
- CR109299
- Other IDs
- 2022-002896-13, NOPRODPBNAP1001, PLATFORMPBNAP1001
- Status last verified
- Mar 2025
- First submitted
- 22 May 2023
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Specific Appendix to PLATFORMPBNAP1001: Evaluation of The Effect of Adalimumab on Inflammatory Mediators Following a Systemic Endotoxin Challenge
- ClinicalTrials.gov ID
- NCT05884242
- Acronym / sponsor ID
- CR109299
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 22 May 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge | Experimental | Drug: Adalimumab, Drug: Lipopolysaccharide (LPS)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. |
| Control Arm: LPS Challenge | Experimental | Drug: Lipopolysaccharide (LPS)Participants will receive LPS IV injection on Day 6. No study interaction will be administered. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: HumiraAdalimumab will be administered subcutaneously. | Drug | Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge |
| Lipopolysaccharide (LPS)LPS will be administered intravenously. | Drug | Active Arm: Adalimumab + Lipopolysaccharide (LPS) Challenge, Control Arm: LPS Challenge |
Primary outcome
Change From Baseline in C-reactive Protein (CRP)
Time frame: From baseline up to Day 14
Change from the baseline in CRP levels will be reported.
6 secondary outcomes
Change From Baseline Tumour Necrosis Factor-alpha (TNF-alpha)
Time frame: From baseline up to Day 14
Longitudinal Change From Baseline in Temperature
Time frame: From baseline up to Day 14
Longitudinal Change From Baseline in Heart Rate
Time frame: From baseline up to Day 14
Longitudinal Change From Baseline in Blood Pressure
Time frame: From baseline up to Day 14
Percentage of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Day 21 (end of study)
Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs)
Time frame: Up to Day 21 (end of study)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Adalimumab and Lipopolysaccharide (LPS) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in C-reactive Protein (CRP) (time frame: From baseline up to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.