Assessment of Mechanistic Blood Biomarkers in Healthy HumansPhase 1NCT01670773
A Study of CAT-1004 Biomarkers in Healthy Subjects
A Phase 1 study testing CAT-1004 and Salsalate + DHA in people with Assessment of Mechanistic Blood Biomarkers in Healthy Humans, run by Catabasis Pharmaceuticals at 1 site in United States.
Trial summary
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Assessment of Mechanistic Blood Biomarkers in Healthy Humans
- What is being tested?
- CAT-1004 and Salsalate + DHA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Oct 2012
- 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
- Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
- BMI between 18 and 30 kg/m2 inclusive
Who cannot join
- Viral or bacterial infection within 21 days prior to randomization
- Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.
- Being tested
- CAT-1004, Salsalate + DHA, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAT-1004Drug
Salsalate + DHADrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| CAT-1004 Dose #1 | Experimental | Single dose #1 Receives: Drug: CAT-1004 |
| Salsalate + DHA | Active comparator | Single dose #2 Receives: Drug: Salsalate + DHA |
| Placebo | Placebo comparator | Single Dose #3 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation
Measured: Pre/post each of 3 Single doses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Assessment of Mechanistic Blood Biomarkers in Healthy HumansStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catabasis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joanne Donovan, MD, PhD, Study director, Catabasis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01670773
- Sponsor's protocol ID
- CAT-1004-103
- Status last verified
- Oct 2012
- First submitted
- 16 Aug 2012
- Last updated
- 30 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single Center, Biomarker Study in Healthy Subjects Receiving Single Doses of CAT-1004
- ClinicalTrials.gov ID
- NCT01670773
- Acronym / sponsor ID
- CAT-1004-103
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Catabasis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 22 Aug 2012 (estimated)
- 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.
This study is being conducted to assess mechanistic blood biomarkers of CAT-1004 in healthy humans.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAT-1004 Dose #1 | Experimental | Drug: CAT-1004Single dose #1 |
| Salsalate + DHA | Active comparator | Drug: Salsalate + DHASingle dose #2 |
| Placebo | Placebo comparator | Drug: PlaceboSingle Dose #3 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Good health as determined by medical history, vital signs, EGC, physical exam and clinical lab results
- BMI between 18 and 30 kg/m2 inclusive
Key exclusion criteria (2 listed)
- Viral or bacterial infection within 21 days prior to randomization
- Use of prescription drugs, nonprescription drugs, herbals and dietary supplements within 7 days prior to randomization
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 |
|---|---|---|
| CAT-1004 | Drug | CAT-1004 Dose #1 |
| Salsalate + DHA | Drug | Salsalate + DHA |
| Placebo | Drug | Placebo |
Primary outcome
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation
Time frame: Pre/post each of 3 Single doses
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 Oct 2012.
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.
Joanne Donovan, MD, PhD study director
Catabasis
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 CAT-1004 and Salsalate + DHA in people with Assessment of Mechanistic Blood Biomarkers in Healthy Humans, run by Catabasis Pharmaceuticals at 1 site in United States.
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 2 inclusion and 2 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 Oct 2012. 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 States. 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?
Change in nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) activity p65 following ex vivo lipopolysaccharide stimulation (time frame: Pre/post each of 3 Single doses). 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 Oct 2012.