Healthy VolunteerPhase 1NCT02486809
A Bioequivalence Study of Subcutaneous (SC) Lebrikizumab Administered by Needle and Syringe or by Prefilled Syringe With Needle Safety Device (PFS-NSD)
A Phase 1 study testing Lebrikizumab in people with Healthy Volunteer, run by Genentech, Inc. at 4 sites in United States.
Trial summary
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Lebrikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2015to Oct 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 32 kg/m^2 and body weight 50 to 100 kg, inclusive
- Nonpregnant and nonlactating females
- Agreement to utilize effective contraception among men and women of childbearing potential
Who cannot join
- Known allergy or hypersensitivity to study drug or components
- History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
- Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
- Biological therapy within 90 days prior to Day -1
- Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
- Receipt of blood products within 2 months prior to study entry
Show all 10Show fewer
- Donation or loss of blood/plasma within up to 6 months prior to study drug, depending upon volume
- Receipt of live attenuated vaccine within 1 month prior to study drug
- Use of tobacco- or nicotine-containing products within 14 days prior to Screening
- Use of any prescription or nonprescription medication within 14 days prior to study drug
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Dallas, Texas, 75247
Study site
Daytona Beach, Florida, 32117
Study site
Evansville, Indiana, 47710
Study site
Madison, Wisconsin, 53704
About this study
Official title: A Phase I, Randomized, Open-Label, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Bioequivalence Between a High-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Needle and Syringe and a Low-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD)
This study will assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.
- Conditions
- Healthy Volunteer
- Being tested
- Lebrikizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LebrikizumabDrug
Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
| Study group | Role | What they receive |
|---|---|---|
| Treatment 1: Needle and Syringe | Experimental | Healthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. Receives: Drug: Lebrikizumab |
| Treatment 2: PFS-NSD | Experimental | Healthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD. Receives: Drug: Lebrikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time to maximum concentration (Tmax) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination rate constant of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination half-life (t1/2) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent clearance (CL/F) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent volume of distribution (Vz/F) of lebrikizumab
Measured: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Secondary outcomes (2)
Incidence of adverse events
Measured: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab
Measured: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02486809
- Sponsor's protocol ID
- GP29651
- Status last verified
- Nov 2016
- First submitted
- 29 Jun 2015
- Last updated
- 2 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Open-Label, Parallel-Group, Single-Dose, Multi-Center Study in Healthy Subjects to Investigate the Bioequivalence Between a High-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Needle and Syringe and a Low-Concentration Formulation of Lebrikizumab Administered Subcutaneously by a Prefilled Syringe With Needle Safety Device (PFS-NSD)
- ClinicalTrials.gov ID
- NCT02486809
- Acronym / sponsor ID
- GP29651
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 1 Jul 2015 (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 assess the bioequivalence in healthy participants between a high-concentration formulation of lebrikizumab withdrawn from a vial and administered SC as a single injection by a needle and syringe, and a low-concentration formulation of lebrikizumab administered SC as a single injection via PFS-NSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment 1: Needle and Syringe | Experimental | Drug: LebrikizumabHealthy volunteers will receive a single SC injection of lebrikizumab, withdrawn from a vial and administered by a needle and syringe. |
| Treatment 2: PFS-NSD | Experimental | Drug: LebrikizumabHealthy volunteers will receive a single SC injection of lebrikizumab, administered by PFS-NSD. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy adults 18 to 65 years of age, inclusive
- Body mass index (BMI) 18 to 32 kg/m^2 and body weight 50 to 100 kg, inclusive
- Nonpregnant and nonlactating females
- Agreement to utilize effective contraception among men and women of childbearing potential
Key exclusion criteria (10 listed)
- Known allergy or hypersensitivity to study drug or components
- History of alcohol or drug abuse within 12 months prior to study drug, or positive test for alcohol or drugs of abuse
- Receipt of an investigational agent within 30 days of 5 half-lives prior to Day -1
- Biological therapy within 90 days prior to Day -1
- Parasitic or Listeria monocytogenes infection within 6 months prior to Screening
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 |
|---|---|---|
| LebrikizumabParticipants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD. | Drug | Treatment 1: Needle and Syringe, Treatment 2: PFS-NSD |
Primary outcome
Maximum observed concentration (Cmax) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Time to maximum concentration (Tmax) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve to the last measurable concentration (AUC0-last) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Area under the concentration-time curve extrapolated to infinity (AUC0-inf) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination rate constant of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent terminal elimination half-life (t1/2) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent clearance (CL/F) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
Apparent volume of distribution (Vz/F) of lebrikizumab
Time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)
2 secondary outcomes
Incidence of adverse events
Time frame: From Day -1 until study completion or premature withdrawal (up to approximately 3 months)
Incidence of anti-therapeutic antibodies (ATAs) to lebrikizumab
Time frame: From Day 1 until study completion or premature withdrawal (up to approximately 3 months)
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 2 Nov 2016.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Clinical Trials study director
Hoffmann-La Roche
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lebrikizumab in people with Healthy Volunteer, run by Genentech, Inc. at 4 sites 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 4 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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?
Maximum observed concentration (Cmax) of lebrikizumab (time frame: Pre-dose and post-dose from Day 1 until study completion or premature withdrawal (up to approximately 3 months)). The study lists 8 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 2 Nov 2016.