AzTrials
AzTrials

HealthyPhase 1NCT03456713

A Study 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.

Official record
Search all trials

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 a solution formulation in different devices. 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
72 participants
Where
1 siteUnited States
Study dates
6 Mar 2018to 13 Aug 2018
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

  • Must be healthy male or female

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, 75247-4989

Other trials in United States

About this study

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

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 a solution formulation in different devices. The tolerability of LY3074828 will also be evaluated and information about any side effects experienced will be collected.

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 NCT03456713
Study groupRoleWhat they receive
Part A: 250 mg LY3074828 (Reference)Experimental250 mg LY3074828 administered subcutaneous (SC) as solution formulation in two prefilled syringes targeting a 5- to 10-second injection time for each injection on day 1.
Receives: Biological: LY3074828
Part A: 250 mg LY3074828 (Test 1)Experimental250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.
Receives: Biological: LY3074828
Part B: 250 mg LY3074828 (Test 2 and Test 3)ExperimentalTest 2: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at slow speed targeting an approximately 13-second injection time on day 1. Test 3: 250 mg LY3074828 administered subcutaneous (SC) as solution formulation in an auto-injector at fast speed targeting an approximately 5-second injection time on day 2.
Receives: Biological: LY3074828
Part B: 125 mg LY3074828 (Test 4 and Test 5)ExperimentalTest 4: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at slow speed targeting an approximately 7-second injection time on day 1. Test 5: 125 mg LY3074828 administered SC as solution formulation in an auto-injector at fast speed targeting an approximately 4.5-second injection time on day 2.
Receives: Biological: LY3074828

What is being measured

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

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828

    Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828

    Measured: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hours

  2. Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3074828

    Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3074828

    Measured: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hours

  3. Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3074828

    Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to tlast (AUC[0-tlast]) of LY3074828

    Measured: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hours

  4. Part A: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including Visual Analog Scale (VAS ) Score)

    Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). Least Squares (LS) mean was calculated using linear fixed-effects model with treatment (Reference or Test 1) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.

    Measured: Day 1, 0 hour

  5. Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 250 mg LY3074828 Slow Versus Fast

    Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 2 or Test 3) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.

    Measured: Day 1, 0 hour

  6. Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 125 mg LY3074828 Slow Versus Fast

    Pain was assessed by the SF-MPQ and quantified using the validated VAS where 0mm represented "no pain" and 100mm represented "worst possible pain". The SF-MPQ total score ranges from 0 to 45 (the higher the total score, the more pain experienced). LS mean was calculated using linear fixed-effects model with treatment (Test 4 or Test 5) as a fixed effect. Model: Log (Score+1) = Treatment + Random Error.

    Measured: Day 1, 0 hour

Timeline

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

  1. First posted7 Mar 2018
  2. Study start6 Mar 2018
  3. Primary completion13 Aug 2018
  4. Study completion13 Aug 2018

Resources

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
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03456713
Sponsor's protocol ID
16617
Other IDs
I6T-MC-AMAQ
Status last verified
Feb 2024
First submitted
5 Mar 2018
Last updated
20 Feb 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

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 1 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 20 Feb 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 20 Feb 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?

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828 (time frame: Day 1: 0, 2, 6; Day 2: 24; Day 4: 72; Day 8: 168; Day 11: 240; Day 15: 336; Day 22: 504; Day 29: 672; Day 43: 1008; Day 57: 1344; Day 71: 1680; Day 85: 2016 hours). The study lists 6 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 NCT03456713.

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 20 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in