HealthyPhase 1NCT04840901

A Study of Lebrikizumab (LY3650150) Administered by Two Different Devices in Healthy Participants

A Phase 1 study testing Lebrikizumab in people with Healthy, run by Eli Lilly and Company at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main purpose of this study is to look at the amount of the study drug, lebrikizumab, that gets into the blood stream and how long it takes the body to get rid of lebrikizumab (LY3650150) when given using either a pre-filled autoinjector (AI) or a pre-filled syringe with needle safety device (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
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: 242 participants
Where: 4 sitesUnited States
Study dates: 2 Jun 2021to 11 Feb 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Are Overtly healthy males or nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation.
Agree not to donate blood or plasma until after the end of their participation in the study
Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)

Who cannot join

Are females who are pregnant or lactating.
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Have a history or presence of psychiatric disorders
Show evidence of human immunodeficiency virus infection.
Show evidence of hepatitis C and/or hepatitis B
Medical history of allergic reaction to humanized monoclonal antibodies

Show all 9Show fewer

Have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or are unable to abide by CRU smoking restrictions

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Covance Dallas
Dallas, Texas, 75247
LabCorp CRU, Inc.
Daytona Beach, Florida, 32117
LabCorp CRU, Inc.
Madison, Wisconsin, 53704
QPS
Springfield, Missouri, 65802

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single-Dose Bioequivalence Study of Injections of Lebrikizumab Using a 2-mL Pre-Filled Syringe With Needle Safety Device and an Investigational 2-mL Autoinjector in Healthy Participants

Conditions: Healthy
Being tested: Lebrikizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LebrikizumabDrug
Also called LY3650150
Administered SC.

Study groups in NCT04840901
Study group	Role	What they receive
Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device	Experimental	2-milliliter (mL) (125 milligrams per milliliter [mg/mL]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD). Receives: Drug: Lebrikizumab
Lebrikizumab (Test) - Autoinjector	Experimental	2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI). Receives: Drug: Lebrikizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab
PK: Cmax of Lebrikizumab
Measured: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab
PK: AUC[0-∞] of Lebrikizumab
Measured: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
PK: AUC[0-tlast] of Lebrikizumab
Measured: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Jun 202111 Feb 2022

First posted12 Apr 2021
Study start2 Jun 2021
Primary completion11 Feb 2022
Study completion11 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 242 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04840901
Sponsor's protocol ID: 17955
Other IDs: J2T-MC-KGBG
Status last verified: Sep 2024
First submitted: 9 Apr 2021
Last updated: 22 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-Dose Bioequivalence Study of Injections of Lebrikizumab Using a 2-mL Pre-Filled Syringe With Needle Safety Device and an Investigational 2-mL Autoinjector in Healthy Participants
ClinicalTrials.gov ID: NCT04840901
Acronym / sponsor ID: 17955
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 242 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 2 Jun 2021 (actual)
Primary completion: 11 Feb 2022 (actual)
Study completion: 11 Feb 2022 (actual)
First posted: 12 Apr 2021 (actual)
Results: Posted 22 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device	Experimental	Drug: Lebrikizumab2-milliliter (mL) (125 milligrams per milliliter [mg/mL]) Lebrikizumab administered subcutaneously (SC) via pre-filled syringe with needle safety device (PFS-NSD).
Lebrikizumab (Test) - Autoinjector	Experimental	Drug: Lebrikizumab2-mL (125 mg/mL) Lebrikizumab administered SC via autoinjector (AI).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Are Overtly healthy males or nonpregnant females of childbearing or non-childbearing potential as determined through medical evaluation.
Agree not to donate blood or plasma until after the end of their participation in the study
Have a body mass index (BMI) within the range 18.0 to 32.0 kilograms per meter squared (kg/m²)

Key exclusion criteria (9 listed)

Are females who are pregnant or lactating.
Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
Have a history or presence of psychiatric disorders
Show evidence of human immunodeficiency virus infection.
Show evidence of hepatitis C and/or hepatitis B

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
LebrikizumabAlso: LY3650150Administered SC.	Drug	Lebrikizumab (Reference) - Pre-Filled Syringe with Needle Safety Device, Lebrikizumab (Test) - Autoinjector

Primary outcome

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: Cmax of Lebrikizumab
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: AUC[0-∞] of Lebrikizumab
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab
Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99
PK: AUC[0-tlast] of Lebrikizumab

Results and safety

Results posted to the registry on 22 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD)	123	118
Lebrikizumab (Test) - Autoinjector (AI)	119	117

Primary outcome: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab

Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (µg/mL)

Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n = 120	Lebrikizumab (Test) - Autoinjector (AI) n = 118
Value	38.5 (31)	41.9 (31)

Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) vs Lebrikizumab (Test) - Autoinjector (AI): Ratio of Geometric LS Mean: 1.09 (90% CI 1.03 to 1.16), ANCOVA

Population analysed: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Lebrikizumab

Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms*day per milliliter (µg*d/mL)

Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n = 106	Lebrikizumab (Test) - Autoinjector (AI) n = 100
Value	1340 (29)	1450 (26)

Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) vs Lebrikizumab (Test) - Autoinjector (AI): Ratio of Geometric LS Mean: 1.07 (90% CI 1.02 to 1.14), ANCOVA

Population analysed: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

Primary outcome: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab

Time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99. Geometric mean (Geometric Coefficient of Variation). Unit: µg*d/mL

Measure	Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) n = 117	Lebrikizumab (Test) - Autoinjector (AI) n = 117
Value	1250 (28)	1360 (25)

Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD) vs Lebrikizumab (Test) - Autoinjector (AI): Ratio of Geometric LS Mean: 1.09 (90% CI 1.03 to 1.14), ANCOVA

Population analysed: All participants who received a full dose of Lebrikizumab and had evaluable PK sample.

Adverse events

Time frame: Up to 99 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lebrikizumab (Reference) - Pre-Filled Syringe With Needle Safety Device (PFS-NSD)	0 of 122 (0%)	39 of 122 (32%)	0 of 122
Lebrikizumab (Test) - Autoinjector (AI)	0 of 119 (0%)	26 of 119 (21.8%)	0 of 119

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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, run by Eli Lilly and Company 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 3 inclusion and 9 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 22 Nov 2024. 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?

Yes. Results are posted in the registry (first posted 22 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Lebrikizumab (time frame: Predose: Day 1, and Postdose: Days 3, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 99). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04840901.

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 22 Nov 2024.