HealthyPhase 1NCT03662100

A Study of Two Formulations of LY3074828 in Healthy Participants

A Phase 1 study testing LY3074828, Auto-injector (AI) and Prefilled syringe (PFS) 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.

Official record

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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, Auto-injector (AI) and Prefilled syringe (PFS)
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2018to 25 Jan 2019
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 8 weeks 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 severe 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 Clinical Research Inc
Daytona Beach, Florida, 32117

Other trials in United States

About this study

Official title: A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects

Screening is required within 28 days prior to the start of the study. For each participant, the study will last about 12 weeks, not including screening.

Conditions: Healthy
Being tested: LY3074828, Auto-injector (AI), Prefilled syringe (PFS)

What participants receive

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

LY3074828Biological
Administered SC
LY3074828Drug
Administered SC
Auto-injector (AI)Device
AI to administer LY3074828
Prefilled syringe (PFS)Device
PFS to administer LY3074828

Study groups in NCT03662100
Study group	Role	What they receive
Test 1: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter [mg/mL]) administered subcutaneously (SC) via an auto-injector (AI) in arm. Receives: Biological: LY3074828; Device: Auto-injector (AI)
Test 2: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh. Receives: Biological: LY3074828; Device: Auto-injector (AI)
Test 3: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen. Receives: Biological: LY3074828; Device: Auto-injector (AI)
Reference 1: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. The second injection was administered 20 (±2) minutes after the first injection. Receives: Drug: LY3074828; Device: Prefilled syringe (PFS)
Reference 2: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection. Receives: Drug: LY3074828; Device: Prefilled syringe (PFS)
Reference 3: 250 mg LY3074828	Experimental	Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection. Receives: Drug: LY3074828; Device: Prefilled syringe (PFS)

What is being measured

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

Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device
Pharmacokinetics: Cmax of LY3074828
Measured: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Measured: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Visual Analogue Scale (VAS) Pain Assessment by Device
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Measured: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Measured: Day 1: 1, 5 (±1.5) and 15 (±2) minutes

Timeline

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

6 Sep 201825 Jan 2019

First posted7 Sep 2018
Study start6 Sep 2018
Primary completion25 Jan 2019
Study completion25 Jan 2019

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: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03662100
Sponsor's protocol ID: 16618
Other IDs: I6T-MC-AMAR
Status last verified: 1 May 2023
First submitted: 5 Sep 2018
Last updated: 25 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: Yes
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?

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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: A Safety, Tolerability, and Pharmacokinetic Study of Injections of LY3074828 Solution Using Investigational 1-mL Pre-filled Syringes and Investigational 2-mL Autoinjector in Healthy Subjects
ClinicalTrials.gov ID: NCT03662100
Acronym / sponsor ID: 16618
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 6 Sep 2018 (actual)
Primary completion: 25 Jan 2019 (actual)
Study completion: 25 Jan 2019 (actual)
First posted: 7 Sep 2018 (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 study will last about 12 weeks, not including screening.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Test 1: 250 mg LY3074828	Experimental	Biological: LY3074828, Device: Auto-injector (AI)Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter [mg/mL]) administered subcutaneously (SC) via an auto-injector (AI) in arm.
Test 2: 250 mg LY3074828	Experimental	Biological: LY3074828, Device: Auto-injector (AI)Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828	Experimental	Biological: LY3074828, Device: Auto-injector (AI)Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
Reference 1: 250 mg LY3074828	Experimental	Drug: LY3074828, Device: Prefilled syringe (PFS)Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm. The second injection was administered 20 (±2) minutes after the first injection.
Reference 2: 250 mg LY3074828	Experimental	Drug: LY3074828, Device: Prefilled syringe (PFS)Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection.
Reference 3: 250 mg LY3074828	Experimental	Drug: LY3074828, Device: Prefilled syringe (PFS)Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen. The second injection was administered 20 (±2) minutes after the first injection.

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 8 weeks 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	Test 1: 250 mg LY3074828, Test 2: 250 mg LY3074828, Test 3: 250 mg LY3074828
LY3074828Administered SC	Drug	Reference 1: 250 mg LY3074828, Reference 2: 250 mg LY3074828, Reference 3: 250 mg LY3074828
Auto-injector (AI)AI to administer LY3074828	Device	Test 1: 250 mg LY3074828, Test 2: 250 mg LY3074828, Test 3: 250 mg LY3074828
Prefilled syringe (PFS)PFS to administer LY3074828	Device	Reference 1: 250 mg LY3074828, Reference 2: 250 mg LY3074828, Reference 3: 250 mg LY3074828

Primary outcome

Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device
Time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Cmax of LY3074828
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device
Time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Visual Analogue Scale (VAS) Pain Assessment by Device
Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes
The VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.

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
Test 1: 250 mg LY3074828	11	11
Test 2: 250 mg LY3074828	11	11
Test 3: 250 mg LY3074828	11	11
Reference 1: 250 mg LY3074828	11	11
Reference 2: 250 mg LY3074828	11	11
Reference 3: 250 mg LY3074828	11	11

Primary outcome: Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device

Time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter (μg/mL)

Measure	250 mg LY3074828 AI n = 33	250 mg LY3074828 PFS n = 33
Value	22.2 (40)	18.7 (34)

Population analysed: All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.

Primary outcome: Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device

Measure	250 mg LY3074828 AI n = 33	250 mg LY3074828 PFS n = 33
Value	357 (38)	340 (38)

Primary outcome: Visual Analogue Scale (VAS) Pain Assessment by Device

Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes. Mean (Standard Deviation). Unit: millimeter

Measure	250 mg LY3074828 AI First Injection n = 33	250 mg LY3074828 PFS First Injection n = 33	250 mg LY3074828 PFS Second Injection n = 33
1 min	25.2 (20.0)	22.6 (18.3)	18.3 (15.1)
5 min (±1.5)	12.0 (15.8)	6.1 (7.0)	6.0 (6.7)
15 min (±2)	1.9 (3.1)	2.4 (2.8)	2.2 (4.3)

Population analysed: All participants who received at least one dose of study drug.

Primary outcome: Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location

Time frame: Day 1: 1, 5 (±1.5) and 15 (±2) minutes. Mean (Standard Deviation). Unit: millimeter

Measure	250 mg LY3074828 AI First Injection n = 33	250 mg LY3074828 PFS First Injection n = 33	250 mg LY3074828 PFS Second Injection n = 33
Arm: 1 min	25.9 (17.2)	19.0 (12.0)	15.6 (12.3)
Arm: 5 min (±1.5)	5.6 (5.4)	4.5 (5.5)	5.0 (6.0)
Arm: 15 min (±2)	2.6 (4.8)	1.8 (2.4)	2.0 (2.9)
Thigh: 1 min	26.8 (15.5)	19.6 (20.9)	20.5 (19.6)
Thigh: 5 min (±1.5)	13.1 (12.3)	6.2 (6.6)	7.9 (7.8)
Thigh:15 min (±2)	0.9 (1.3)	3.0 (3.6)	3.5 (6.7)
Abdomen: 1 min	22.9 (27.2)	29.2 (20.6)	18.7 (13.4)
Abdomen: 5 min (±1.5)	17.4 (23.3)	7.5 (8.8)	5.0 (6.4)

Population analysed: All participants who received at least one dose of study drug.

Adverse events

Time frame: Up To 85 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test 1: 250 mg LY3074828	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Test 2: 250 mg LY3074828	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
Test 3: 250 mg LY3074828	0 of 11 (0%)	2 of 11 (18.2%)	0 of 11
Reference 1: 250 mg LY3074828	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Reference 2: 250 mg LY3074828	0 of 11 (0%)	6 of 11 (54.5%)	0 of 11
Reference 3: 250 mg LY3074828	0 of 11 (0%)	4 of 11 (36.4%)	0 of 11

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.
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

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, Auto-injector (AI) and Prefilled syringe (PFS) 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: Maximum Concentration (Cmax) of LY3074828 by Device (time frame: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose). The study lists 4 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 NCT03662100.

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.