Adult Healthy VolunteersPhase 1NCT01885624
Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
A Phase 1 study testing TAB08 in people with Adult Healthy Volunteers, run by Theramab LLC at 1 site in Russia.
Trial summary
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. 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
- Adult Healthy Volunteers
- What is being tested?
- TAB08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteRussia
- Study dates
- Nov 2011to Jun 2013
- 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
- Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
- Body mass is at least 60 kg and BMI is within 20-27
- Volunteer is in good physical and mental health, as per his medical history and assessment results
- Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
- Volunteer has signed the informed concent.
Who cannot join
- Any chronic or relapsing illness in the medical history
- Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
- Active tuberculosis at the time of screening
- Any acute illness at the time of study enrollment
- Any blood donation within 4 weeks before Study Day 1
- Positive result for HBsAG, Hepatitis C, HIV
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- Continuous use af any medications
- Use of any medications within 72 hours before study drug infusion
- Use of an investigational treatment within 4 weeks before screening, or within a period of 5 half-lives of the investigational treatment, whichever is longer
- High inflammatory cytokines levels as per RESTORE test results after ex vivo PBMC testing
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.
- Conditions
- Adult Healthy Volunteers
- Being tested
- TAB08
- Keywords
- TAB08, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAB08Biological
monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| TAB08 | Experimental | Single TAB08 i.v. infusion Receives: Biological: TAB08 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity in every dose cohort
Measured: From study drug infusion (Day 1) untill the end of study (Day 71/141)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Healthy VolunteersStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theramab LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olga B Ershova, Prof., Principal investigator, Clinical Emergency Hospital of Yaroslavl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885624
- Sponsor's protocol ID
- TAB08/HS/R1
- Status last verified
- Feb 2017
- First submitted
- 19 Jun 2013
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Phase 1 Pharmacokinetics and Tolerability Study of Single TAB08 Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01885624
- Acronym / sponsor ID
- TAB08/HS/R1
- Conditions
- Adult Healthy Volunteers
- Keywords
- TAB08, healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Theramab LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 25 Jun 2013 (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.
The purpose of this study is to assess safety and tolerability of ascending dosed of TAB08 after single i.v. infusion to the adult healthy volunteers. Additionally were assessed infusion speed tolerability, pharmacokinetics and pharmacodynamics of TAB08 after single i.v. infusion and to explore TAB mechanism-of-action biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TAB08 | Experimental | Biological: TAB08Single TAB08 i.v. infusion |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult man aged from 18 to 40 years, who agreed to use adequate contraception.
- Body mass is at least 60 kg and BMI is within 20-27
- Volunteer is in good physical and mental health, as per his medical history and assessment results
- Volunteer's laboratory values are normal (or not clinically significant as per Investigator discretion) at screening, including baseline cytokines levels as per RESTORE test results
- Volunteer has signed the informed concent.
Key exclusion criteria (10 listed)
- Any chronic or relapsing illness in the medical history
- Any abnormal assessment or laboratory result at screening, which is clinically significant as per Investigator discretion
- Active tuberculosis at the time of screening
- Any acute illness at the time of study enrollment
- Any blood donation within 4 weeks before 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 |
|---|---|---|
| TAB08monoclonal antibody | Biological | TAB08 |
Primary outcome
Incidence of dose-limiting toxicity in every dose cohort
Time frame: From study drug infusion (Day 1) untill the end of study (Day 71/141)
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 15 Feb 2017.
- 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.
Olga B Ershova, Prof. principal investigator
Clinical Emergency Hospital of Yaroslavl
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 TAB08 in people with Adult Healthy Volunteers, run by Theramab LLC at 1 site in Russia.
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 10 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 15 Feb 2017. 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 Russia. 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?
Incidence of dose-limiting toxicity in every dose cohort (time frame: From study drug infusion (Day 1) untill the end of study (Day 71/141)). 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 15 Feb 2017.