Traumatic Brain InjuryPhase 1NCT01357421
Effects of TT301 on Cytokine Levels Post Endotoxin Challenge
A Phase 1 study testing TT301 in people with Traumatic Brain Injury, run by OPKO Health, Inc. at 1 site in United States.
Trial summary
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- TT301
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Jun 2011
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18 to 40 years, inclusive
- 55 - 95 kg, inclusive
Who cannot join
- Evidence of any clinically significant disease
- History of cancer
- History of syncope or severe vasovagal events
- Antibiotic treatment within 60 days of Day 1
- Surgical procedure within 60 days of Day 1
- Hepatitis C, Hepatitis B
Show all 15Show fewer
- Tuberculosis
- HIV
- Requirement for medications (prescription/OTC) during the study
- Donated > 250 mL blood within 30 days of Day 1
- Donated > 750 mL blood within 60 days of Day 1
- In a clinical trial of an immunosuppressive drug within 6 months of Day 1
- Received any vaccination within 6 months of Day 1
- Any clinically important allergy
- Known allergy/sensitivity to lactose and/or polyethylene glycol
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Unit
Durham, North Carolina, 27710
About this study
Official title: A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers
This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Read the detailed description
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
- Conditions
- Traumatic Brain Injury
- Being tested
- TT301, Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TT301Drug
Also called TT301 iv
Single iv dose of TT301
PlaceboDrug
Also called 0.9% sodium chloride for injection USP
Single iv dose of 0.9% sodium chloride for injection USP
| Study group | Role | What they receive |
|---|---|---|
| TT301 | Experimental | Investigational drug TT301 Receives: Drug: TT301 |
| Placebo | Placebo comparator | Normal saline Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine levels post LPS challenge
Measured: Measured up to 12h post-LPS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startMay 2011
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPKO Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Agensky, BSc, MBA, Study director, Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357421
- Sponsor's protocol ID
- NMX-103
- Status last verified
- Jun 2013
- First submitted
- 13 May 2011
- Last updated
- 6 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-blind, Randomized, Placebo-controlled Study Evaluating the Effects of a Single Intravenous Dose of TT301 on LPS-induced Changes in Blood Cytokine Levels in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01357421
- Acronym / sponsor ID
- NMX-103
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- OPKO Health, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 May 2011 (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 will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Detailed description
The LPS human endotoxemia model results in a well characterized, transient acute inflammatory response. The model has been widely used for decades as a system to study new therapeutic agents for inflammation before wider clinical studies are undertaken. This study will evaluate the effects of TT301 on cytokine levels in healthy male volunteers participating in an endotoxin challenge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TT301 | Experimental | Drug: TT301Investigational drug TT301 |
| Placebo | Placebo comparator | Drug: PlaceboNormal saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male
- 18 to 40 years, inclusive
- 55 - 95 kg, inclusive
Key exclusion criteria (15 listed)
- Evidence of any clinically significant disease
- History of cancer
- History of syncope or severe vasovagal events
- Antibiotic treatment within 60 days of Day 1
- Surgical procedure within 60 days of 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 |
|---|---|---|
| TT301Also: TT301 ivSingle iv dose of TT301 | Drug | TT301 |
| PlaceboAlso: 0.9% sodium chloride for injection USPSingle iv dose of 0.9% sodium chloride for injection USP | Drug | Placebo |
Primary outcome
Cytokine levels post LPS challenge
Time frame: Measured up to 12h post-LPS
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 6 Jun 2013.
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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.
Laura Agensky, BSc, MBA study director
Transition Therapeutics Inc. / Waratah Pharmaceuticals Inc.
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 TT301 in people with Traumatic Brain Injury, run by OPKO Health, Inc. 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 3 inclusion and 15 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 6 Jun 2013. 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?
Cytokine levels post LPS challenge (time frame: Measured up to 12h post-LPS). 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 6 Jun 2013.