HealthyPhase 1NCT03188510

A Study of Two Different Formulations of LY3074828 in Healthy Participants

A Phase 1 study testing LY3074828 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

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

Trial summary

The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given as different formulations. 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?: LY3074828
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteUnited States
Study dates: 30 Jun 2017to 27 Nov 2017
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

None listed.

Who cannot join

Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
Must not show evidence of active or latent tuberculosis (TB)
Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
Must not have been treated with steroids within 1 month of screening, or intend to during the study
Must not be immunocompromised
Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1

Show all 10Show fewer

Must not have significant allergies to humanised monoclonal antibodies
Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
Must not 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
Must not have had breast cancer within the past 10 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: Relative Bioavailability of LY3074828 Solution Formulation in Pre-Filled Syringes Compared to Lyophilized Formulation After Single Subcutaneous Administration

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.

Conditions: Healthy
Being tested: LY3074828

What participants receive

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

LY3074828Biological
Administered SC

Study groups in NCT03188510
Study group	Role	What they receive
Reference: 250 mg LY3074828	Experimental	250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections Receives: Biological: LY3074828
Test 1: 250 mg LY3074828	Experimental	250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes Receives: Biological: LY3074828
Test 2: 500 mg LY3074828	Experimental	500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes Receives: Biological: LY3074828

What is being measured

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

Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 was evaluated. Unit of measure expansion: microgram*day per milliliter per milligram (µg*day/mL/mg).
Measured: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 was evaluated.
Measured: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose

Secondary outcomes (1)

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Number of participants with positive treatment emergent anti-drug antibodies was summarized by treatment group. A treatment-emergent ADA (TEADA) was defined as: having a negative ADA at baseline and an ADA titer greater than or equal to 1:20 (that is (i.e.), greater than 2-fold from the minimal required dilution of 1:10) any time post baseline (i.e., treatment-induced); or a 4-fold or greater change in ADA titer from baseline for participants that had a detectable ADA titer at baseline (i.e., treatment boosted).
Measured: Predose Day 1 Through Day 85

Timeline

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

30 Jun 201727 Nov 2017

First posted15 Jun 2017
Study start30 Jun 2017
Primary completion27 Nov 2017
Study completion27 Nov 2017

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: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03188510
Sponsor's protocol ID: 16455
Other IDs: I6T-MC-AMAE
Status last verified: May 2023
First submitted: 13 Jun 2017
Last updated: 25 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: 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 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Relative Bioavailability of LY3074828 Solution Formulation in Pre-Filled Syringes Compared to Lyophilized Formulation After Single Subcutaneous Administration
ClinicalTrials.gov ID: NCT03188510
Acronym / sponsor ID: 16455
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 30 Jun 2017 (actual)
Primary completion: 27 Nov 2017 (actual)
Study completion: 27 Nov 2017 (actual)
First posted: 15 Jun 2017 (actual)
Results: Posted 25 Jan 2024

Clinical summary

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

Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 13 weeks, not including screening.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Reference: 250 mg LY3074828	Experimental	Biological: LY3074828250 mg LY3074828 lyophilized formulation administered subcutaneously (SC) as 3 injections
Test 1: 250 mg LY3074828	Experimental	Biological: LY3074828250 mg LY3074828 solution formulation administered as SC injections in two prefilled syringes
Test 2: 500 mg LY3074828	Experimental	Biological: LY3074828500 mg LY3074828 solution formulation administered as SC injections in four prefilled syringes

Who may qualify

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

Key inclusion criteria (0 listed)

Key exclusion criteria (10 listed)

Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
Must not show evidence of active or latent tuberculosis (TB)
Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
Must not have been treated with steroids within 1 month of screening, or intend to during the study
Must not be immunocompromised

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
LY3074828Administered SC	Biological	Reference: 250 mg LY3074828, Test 1: 250 mg LY3074828, Test 2: 500 mg LY3074828

Primary outcome

Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828
Time frame: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 was evaluated. Unit of measure expansion: microgram*day per milliliter per milligram (µg*day/mL/mg).
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828
Time frame: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose
PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828 was evaluated.

1 secondary outcome

Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Time frame: Predose Day 1 Through Day 85

Results and safety

Results posted to the registry on 25 Jan 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
Reference: 250 mg LY3074828	18	18
Test 1: 250 mg LY3074828	18	17
Test 2: 500 mg LY3074828	18	18

Primary outcome: Pharmacokinetics (PK): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828

Time frame: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: µg*day/mL/mg

Measure	Reference: 250 mg LY3074828 n = 18	Test 1: 250 mg LY3074828 n = 17	Test 2: 500 mg LY3074828 n = 18
Value	1.06 (27)	1.03 (40)	1.04 (32)

Reference: 250 mg LY3074828 vs Test 1: 250 mg LY3074828: Ratio of geometric least squares means: 0.971 (90% CI 0.805 to 1.17)
Test 1: 250 mg LY3074828 vs Test 2: 500 mg LY3074828: Ratio of geometric least squares means: 1.01 (90% CI 0.841 to 1.22)
Reference: 250 mg LY3074828 vs Test 2: 500 mg LY3074828: Ratio of geometric least squares means: 0.985 (90% CI 0.819 to 1.18)

Population analysed: All enrolled participants who received at least one dose of LY3074828 and have evaluable PK data.

Primary outcome: PK: Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Infinity (DN-AUC[0-∞]) of LY3074828

Time frame: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: µg.day/mL/mg

Measure	Reference: 250 mg LY3074828 n = 18	Test 1: 250 mg LY3074828 n = 17	Test 2: 500 mg LY3074828 n = 18
Value	1.07 (27)	1.05 (40)	1.05 (32)

Reference: 250 mg LY3074828 vs Test 1: 250 mg LY3074828: Ratio of geometric least squares means: 0.978 (90% CI 0.811 to 1.18)
Test 1: 250 mg LY3074828 vs Test 2: 500 mg LY3074828: Ratio of geometric least squares means: 1.00 (90% CI 0.833 to 1.21)
Reference: 250 mg LY3074828 vs Test 2: 500 mg LY3074828: Ratio of geometric least squares means: 0.982 (90% CI 0.817 to 1.18)

Population analysed: All enrolled participants who received at least one dose of LY3074828 and have evaluable PK data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 85 days after administration of study drug. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Reference: 250 mg LY3074828	0 of 18 (0%)	16 of 18 (88.9%)	0 of 18
Test 1: 250 mg LY3074828	0 of 18 (0%)	15 of 18 (83.3%)	0 of 18
Test 2: 500 mg LY3074828	0 of 18 (0%)	18 of 18 (100%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

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 LY3074828 in people with Healthy, run by Eli Lilly and Company 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 0 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 25 Jan 2024. 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. 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 25 Jan 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): Dose-normalized Area Under the Serum Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (DN-AUC[0-tlast]) of LY3074828 (time frame: Predose; 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680 and 2016 hours postdose). The study lists 2 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 NCT03188510.

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 25 Jan 2024.