Bioavailability and PharmacokineticsPhase 1NCT01991509
Safety and Bioavailability of IV and SC LBR-101
A Phase 1 study testing LBR-101 IV and LBR-101 SC in people with Bioavailability and Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability and Pharmacokinetics
- What is being tested?
- LBR-101 IV and LBR-101 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule
Who cannot join
- Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or positive drug/alcohol screen, History of hypersensitivity to injected proteins or monoclonal antibodies, Unwilling or unable to comply with the protocol specified lifestyle guidelines, Investigational site staff members, Use of 3 or more prescription or non-prescription medications daily, Acetaminophen use in doses of higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment with an investigational drug within 30 days of dosing, Use of biologics within 6 months of screening, Any clinically significant abnormality in the 12-Lead ECG, Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study Assessing the Safety, Tolerability and Pharmacokinetics of Two Different Doses of LBR-101 Given Intravenously and Subcutaneously
The purpose of this study is to assess the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.
- Conditions
- Bioavailability and Pharmacokinetics
- Being tested
- LBR-101 IV, LBR-101 SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBR-101 IVBiological
LBR-101 Administered Intravenously
LBR-101 SCBiological
LBR-101 Administered Subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| LBR-101 IV Dose 1 | Experimental | LBR-101 Dose 1 Administered Intravenously Receives: Biological: LBR-101 IV |
| LBR-101 SC Dose 1 | Experimental | LBR-101 Dose 1 Administered Subcutaneously Receives: Biological: LBR-101 SC |
| Placebo IV | Placebo comparator | Placebo Administered Intravenously Receives: Biological: LBR-101 IV |
| Placebo SC | Placebo comparator | Placebo Administered Subcutaneously Receives: Biological: LBR-101 SC |
| LBR-101 Dose 2 IV | Experimental | LBR-101 Dose 2 Administered Intravenously Receives: Biological: LBR-101 IV |
| LBR-101 Dose 2 SC | Experimental | LBR-101 Dose 2 Administered Subcutaneously Receives: Biological: LBR-101 SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of IV versus SC Administration of LBR-101
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bioavailability and PharmacokineticsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcelo Bigal, MD, PhD, Study chair, Sponsor Chief Medical OfficerRafael Escandon, PhD MPH, Study director, Sponsor Clinical VP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991509
- Sponsor's protocol ID
- LBR-101-011
- Status last verified
- Mar 2015
- First submitted
- 12 Nov 2013
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study Assessing the Safety, Tolerability and Pharmacokinetics of Two Different Doses of LBR-101 Given Intravenously and Subcutaneously
- ClinicalTrials.gov ID
- NCT01991509
- Acronym / sponsor ID
- LBR-101-011
- Conditions
- Bioavailability and Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 25 Nov 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 the safety, tolerability and blood levels of LBR-101 when administered intravenously or subcutaneously to healthy volunteers.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LBR-101 IV Dose 1 | Experimental | Biological: LBR-101 IVLBR-101 Dose 1 Administered Intravenously |
| LBR-101 SC Dose 1 | Experimental | Biological: LBR-101 SCLBR-101 Dose 1 Administered Subcutaneously |
| Placebo IV | Placebo comparator | Biological: LBR-101 IVPlacebo Administered Intravenously |
| Placebo SC | Placebo comparator | Biological: LBR-101 SCPlacebo Administered Subcutaneously |
| LBR-101 Dose 2 IV | Experimental | Biological: LBR-101 IVLBR-101 Dose 2 Administered Intravenously |
| LBR-101 Dose 2 SC | Experimental | Biological: LBR-101 SCLBR-101 Dose 2 Administered Subcutaneously |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Generally Healthy, Signed Approved Informed Consent, BMI 17.5-34.5 kg/m2, Willing and able to comply with CRU rules regulations and study schedule
Key exclusion criteria (1 listed)
- Clinically significant medical or psychiatric condition, Febrile illness within 5 days of dosing, Pregnant or Nursing Females. History of alcoholism, drug addiction or positive drug/alcohol screen, History of hypersensitivity to injected proteins or monoclonal antibodies, Unwilling or unable to comply with the protocol specified lifestyle guidelines, Investigational site staff members, Use of 3 or more prescription or non-prescription medications daily, Acetaminophen use in doses of higher than 1 g or more/day, Daily Aspirin use in higher than 325 mg/day, Treatment with an investigational drug within 30 days of dosing, Use of biologics within 6 months of screening, Any clinically significant abnormality in the 12-Lead ECG, Positive result for HIV, Hepatitis B, or Hepatitis C, Any clinically significant abnormalities in Blood Chemistry Hematology or Urinalysis, Positive Pregnancy Test.
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 |
|---|---|---|
| LBR-101 IVLBR-101 Administered Intravenously | Biological | LBR-101 Dose 2 IV, LBR-101 IV Dose 1, Placebo IV |
| LBR-101 SCLBR-101 Administered Subcutaneously | Biological | LBR-101 Dose 2 SC, LBR-101 SC Dose 1, Placebo SC |
Primary outcome
Relative bioavailability of IV versus SC Administration of LBR-101
Time frame: 30 Days
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 4 Mar 2015.
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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.
Marcelo Bigal, MD, PhD study chair
Sponsor Chief Medical Officer
Rafael Escandon, PhD MPH study director
Sponsor Clinical VP
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 LBR-101 IV and LBR-101 SC in people with Bioavailability and Pharmacokinetics, run by Teva Branded Pharmaceutical Products R&D, 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 1 inclusion and 1 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 4 Mar 2015. 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?
Relative bioavailability of IV versus SC Administration of LBR-101 (time frame: 30 Days). 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 4 Mar 2015.