Influenza, HumanPhase 1NCT05765955
Effects of p38 MAPK Inhibitor POLB 001 on in Vivo LPS Challenge Responses
A Phase 1 study testing POLB 001 in people with Influenza, Human, run by Poolbeg Pharma plc at 1 site in Netherlands.
Trial summary
A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Influenza, Human
- What is being tested?
- POLB 001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 22 Jul 2022to 16 Dec 2022
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers aged 18 to 55 years, inclusive.
- BMI in the range of 18 to 32 kg/m2 a minimum body weight of 50 kg.
- Fitzpatrick skin type I-III.
- Able to give written informed consent and willing to comply with all study-related procedures.
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Who cannot join
- (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator.
- History of sepsis, cardiovascular disease or malignancy.
- History of trauma with likely damage to the spleen or surgery to spleen.
- History of alcohol or drug abuse.
- Any clinically significant febrile illness 30 days preceding study Day 1.
- History of serious bleeding.
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- Clinical evidence of significant or unstable medical illness including neurological, hematological, cardiovascular (including clinically significant arrhythmia), hepatic, pulmonary, metabolic, gastrointestinal, renal, psychiatric, endocrine, or infectious diseases or malignancies. Subjects who have had splenectomy.
- Previous participation in a systemic (i.v./inhaled) LPS challenge trial within a year before the first study day.
- Have any current and / or recurrent pathologically, clinically significant skin condition at the lower forearms (i.e., atopic dermatitis) including tattoos.
- Antibiotic use, operation or intervention by surgeon/dentist within one month before the first study day.
- Subjects who have used any prescribed or non-prescribed systemic or topical medication (including herbal remedies) within 7 days of the first dose administration, or less than 5 half-lives (whichever is longer), and during the study (except for vitamin/mineral supplements) unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
- Subjects who have received any medications, including St John's Wort, known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration unless, in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise safety.
- Any active inflammatory or infectious disease (e.g., periodontitis).
- Known immunodeficiency.
- Positive test results for Hepatitis B, Hepatitis C, HIV antibody.
- Subjects who consume on average more than 3 units of alcohol per day (one alcohol unit =1 beer [12 oz] =1 wine [5 oz] =1 spirits [1.5 oz]) or are unable to abstain from using alcohol during the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, PK and the Immunosuppressive Effects of p38 MAPK Inhibitor POLB 001 on the Intradermal and Intravenous LPS Challenge Response in Healthy Volunteers
A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers.
- Conditions
- Influenza, Human
- Being tested
- POLB 001, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POLB 001Drug
Investigational Medicinal Product
PlaceboDrug
Matching Placebo
| Study group | Role | What they receive |
|---|---|---|
| POLB 001 30 mg | Active comparator | Not described Receives: Drug: POLB 001 |
| POLB 001 70 mg | Active comparator | Not described Receives: Drug: POLB 001 |
| POLB 001 150 mg | Active comparator | Not described Receives: Drug: POLB 001 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of intradermal LPS challenge
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers
Endpoints:
Skin response by imaging
- Erythema (multispectral imaging) (Clinician's Erythema Assessment (CEA) Scale)
Measured: 16 days
Effect of intradermal LPS challenge
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers
Endpoints:
Blister exudate analysis
- Flow cytometry (neutrophils, monocyte subsets, T cells, B cells, NK cells, dendritic cells) (10*9/L)
Measured: 16 days
Effect of intradermal LPS challenge
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers
Endpoints:
Blister exudate analysis
- Cytokines (IL-6, IL-8, TNF, IL-1β) (pg/mL)
Measured: 16 days
Effect of intravenous LPS challenge
To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers
Endpoints:
Blood
- Cytokines (IL-6, IL-8, IL-10, TNF, IL-1β) (pg/mL)
Measured: 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start22 Jul 2022
- Primary completion14 Dec 2022
- Study completion16 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poolbeg Pharma plc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765955
- Sponsor's protocol ID
- CHDR2149
- Status last verified
- Mar 2023
- First submitted
- 28 Jul 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, PK and the Immunosuppressive Effects of p38 MAPK Inhibitor POLB 001 on the Intradermal and Intravenous LPS Challenge Response in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05765955
- Acronym / sponsor ID
- CHDR2149
- Conditions
- Influenza, Human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Poolbeg Pharma plcIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2022 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 13 Mar 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.
A single center trial to evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| POLB 001 30 mg | Active comparator | Drug: POLB 001 |
| POLB 001 70 mg | Active comparator | Drug: POLB 001 |
| POLB 001 150 mg | Active comparator | Drug: POLB 001 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male volunteers aged 18 to 55 years, inclusive.
- BMI in the range of 18 to 32 kg/m2 a minimum body weight of 50 kg.
- Fitzpatrick skin type I-III.
- Able to give written informed consent and willing to comply with all study-related procedures.
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions.
Key exclusion criteria (16 listed)
- (A history of) any clinically significant medical condition or abnormalities, as judged by the investigator.
- History of sepsis, cardiovascular disease or malignancy.
- History of trauma with likely damage to the spleen or surgery to spleen.
- History of alcohol or drug abuse.
- Any clinically significant febrile illness 30 days preceding study Day 1.
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 |
|---|---|---|
| POLB 001Investigational Medicinal Product | Drug | POLB 001 150 mg, POLB 001 30 mg, POLB 001 70 mg |
| PlaceboMatching Placebo | Drug | Placebo |
Primary outcome
Effect of intradermal LPS challenge
Time frame: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Skin response by imaging - Erythema (multispectral imaging) (Clinician's Erythema Assessment (CEA) Scale)
Effect of intradermal LPS challenge
Time frame: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Blister exudate analysis - Flow cytometry (neutrophils, monocyte subsets, T cells, B cells, NK cells, dendritic cells) (10*9/L)
Effect of intradermal LPS challenge
Time frame: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intradermal LPS challenge in healthy volunteers Endpoints: Blister exudate analysis - Cytokines (IL-6, IL-8, TNF, IL-1β) (pg/mL)
Effect of intravenous LPS challenge
Time frame: 16 days
To evaluate the effect of POLB 001 on inflammatory responses following an intravenous LPS challenge in healthy volunteers Endpoints: Blood - Cytokines (IL-6, IL-8, IL-10, TNF, IL-1β) (pg/mL)
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 14 Mar 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 POLB 001 in people with Influenza, Human, run by Poolbeg Pharma plc at 1 site in Netherlands.
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 5 inclusion and 16 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 14 Mar 2023. 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 Netherlands. 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. Some participants in this study may receive a placebo. 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?
Effect of intradermal LPS challenge (time frame: 16 days). The study lists 4 primary outcomes in all. 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 14 Mar 2023.