Inflammatory ResponsePhase 1NCT04105959
A Study to Investigate the Effects of RIST4721 on the Inflammatory Response in Healthy Male Subjects Using a Blister Model
A Phase 1 study testing RIST4721 in people with Inflammatory Response, run by Aristea Therapeutics, Inc. at 1 site in United Kingdom.
Trial summary
A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model 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
- Inflammatory Response
- What is being tested?
- RIST4721
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jul 2019to 9 Dec 2019
- 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
- Subject is male, with Fitzpatrick skin types 1 to 3
- Subject is aged between 18 to 55 years, inclusive
- Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- Healthy as determined by a responsible physician, based on medical evaluation
- Must be willing to use birth control as indicated
Who cannot join
- Subject is known to have immune deficiency or is immunocompromised
- Subject has had a recent acute infection or chronic infection
- Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug
- Clinically relevant history of abnormal physical or mental health (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
- Conditions
- Inflammatory Response
- Being tested
- RIST4721, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIST4721Drug
RIST4721 oral solution
PlaceboDrug
Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| RIST4721 300mg | Experimental | RIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover. Receives: Drug: RIST4721; Drug: Placebo |
| RIST4721 150mg | Experimental | RIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover. Receives: Drug: RIST4721; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Measured: Blister formation to Hour 24
Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Measured: Blister formation to Hour 30
Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Measured: Blister formation to Hour 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start25 Jul 2019
- Primary completion19 Nov 2019
- Study completion9 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristea Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105959
- Sponsor's protocol ID
- RIST4721-102
- Status last verified
- Jun 2020
- First submitted
- 23 Sep 2019
- Last updated
- 29 Jun 2020
- 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 29 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
- ClinicalTrials.gov ID
- NCT04105959
- Acronym / sponsor ID
- RIST4721-102
- Conditions
- Inflammatory Response
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Aristea Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 19 Nov 2019 (actual)
- Study completion
- 9 Dec 2019 (actual)
- First posted
- 26 Sep 2019 (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 Randomised, Single-Blind, Placebo-Controlled, Crossover Study to Investigate the Effects of RIST4721, a Novel CXCR2 Inhibitor, on the Inflammatory Response in Healthy Male Subjects Using a Standardized Blister Model
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIST4721 300mg | Experimental | Drug: RIST4721, Drug: PlaceboRIST4721 as once-daily 300mg oral solution for 6 days with a placebo crossover. |
| RIST4721 150mg | Experimental | Drug: RIST4721, Drug: PlaceboRIST4721 as once-daily 150mg oral solution for 6 days with a placebo crossover. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subject is male, with Fitzpatrick skin types 1 to 3
- Subject is aged between 18 to 55 years, inclusive
- Subject has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
- Healthy as determined by a responsible physician, based on medical evaluation
- Must be willing to use birth control as indicated
Key exclusion criteria (4 listed)
- Subject is known to have immune deficiency or is immunocompromised
- Subject has had a recent acute infection or chronic infection
- Subject has a known or suspected allergy or contraindications to cantharidin (blister induction method), RIST4721 or any component of the study drug
- Clinically relevant history of abnormal physical or mental health (including [but not limited to], neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder)
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 |
|---|---|---|
| RIST4721RIST4721 oral solution | Drug | RIST4721 150mg, RIST4721 300mg |
| PlaceboPlacebo oral solution | Drug | RIST4721 150mg, RIST4721 300mg |
Primary outcome
Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo
Time frame: Blister formation to Hour 24
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Absolute neutrophil count in blister fluid at 30 hours post-blister formation compared to placebo
Time frame: Blister formation to Hour 30
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
Absolute neutrophil count in blister fluid at 36 hours post-blister formation compared to placebo
Time frame: Blister formation to Hour 36
Blister fluid will be harvested at 24, 30, and 36 hours post-blister formation and neutrophil count will be assessed at each time point and compared to placebo control
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 29 Jun 2020.
- 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 RIST4721 in people with Inflammatory Response, run by Aristea Therapeutics, Inc. at 1 site in United Kingdom.
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 4 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 29 Jun 2020. 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 United Kingdom. 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?
Absolute neutrophil count in blister fluid at 24 hours post-blister formation compared to placebo (time frame: Blister formation to Hour 24). The study lists 3 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 29 Jun 2020.