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CompletedNCT03456713Updated Feb 20, 2024Results posted

A Study of LY3074828 in Healthy Participants

A Phase 1 interventional study of LY3074828 in Healthy, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
72
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Healthy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Must be healthy male or female

Exclusion criteria

Exclusion Criteria:

  • 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
  • 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
04

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Part A: 250 mg LY3074828 (Reference)

    250 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.

    Biological: LY3074828

  • Experimental
    Part A: 250 mg LY3074828 (Test 1)

    250 mg LY3074828 administered SC as solution formulation in a prefilled syringe targeting a 5- to 15-second injection time on day 1.

    Biological: LY3074828

  • Experimental
    Part B: 250 mg LY3074828 (Test 2 and Test 3)

    Test 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.

    Biological: LY3074828

  • Experimental
    Part B: 125 mg LY3074828 (Test 4 and Test 5)

    Test 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.

    Biological: LY3074828

Interventions

  • BiologicalLY3074828

    Administered SC

05

What researchers measure

Primary outcomes

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

    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

  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

    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

  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

    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

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Day 1, 0 hour

06

Results

Posted Feb 20, 2024

Participant flow

Participant flow — Overall Study
MilestonePart A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)
Started18181818
Received at least one dose of study drug18181818
Completed17181818
Not completed1000
Withdrew: Lost to follow-up1000

Outcome measures

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

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
Reported as:
Geometric mean · microgram per milliliters (μg/mL)
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3074828
microgram per milliliters (μg/mL)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY307482814.4 ± 6721.1 ± 34
Statistical analysis
  • Part A: 250 mg LY3074828 (Reference) vs Part A: 250 mg LY3074828 (Test 1) · Ratio of geometric least squares mean: 1.47 · 90% CI 1.12 to 1.94
PrimaryPart 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

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
Reported as:
Geometric mean · Microgram*Day per Milliliters(μg*day/mL)
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3074828
Microgram*Day per Milliliters(μg*day/mL)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3074828240 ± 46346 ± 33
Statistical analysis
  • Part A: 250 mg LY3074828 (Reference) vs Part A: 250 mg LY3074828 (Test 1) · Ratio of geometric least squares mean: 1.44 · 90% CI 1.15 to 1.81
PrimaryPart 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

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
Reported as:
Geometric mean · Microgram*Day per Milliliters(μg*day/mL)
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3074828
Microgram*Day per Milliliters(μg*day/mL)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)
Part A PK: Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of LY3074828205 ± 54341 ± 33
Statistical analysis
  • Part A: 250 mg LY3074828 (Reference) vs Part A: 250 mg LY3074828 (Test 1) · Ratio of geometric least squares mean: 1.66 · 90% CI 1.31 to 2.11
PrimaryPart 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.

Time frame:
Day 1, 0 hour
Reported as:
Geometric least squares mean · units on a scale
Part A: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including Visual Analog Scale (VAS ) Score)
units on a scalePart A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)
Part A: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including Visual Analog Scale (VAS ) Score)4.16 (2.88 to 6.01)3.04 (2.10 to 4.39)
Statistical analysis
  • Part A: 250 mg LY3074828 (Reference) vs Part A: 250 mg LY3074828 (Test 1) · Ratio of geometric least squares means: 0.73 · 90% CI 0.43 to 1.23
PrimaryPart 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.

Time frame:
Day 1, 0 hour
Reported as:
Geometric least squares mean · units on a scale
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 250 mg LY3074828 Slow Versus Fast
units on a scalePart B: 250 mg LY3074828 (Test 2)Part B: 250 mg LY3074828 (Test 3)
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 250 mg LY3074828 Slow Versus Fast5.06 (3.48 to 7.36)4.96 (3.41 to 7.22)
Statistical analysis
  • Part B: 250 mg LY3074828 (Test 2) vs Part B: 250 mg LY3074828 (Test 3) · Ratio of geometric least squares mean: 0.98 · 90% CI 0.58 to 1.67
PrimaryPart 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.

Time frame:
Day 1, 0 hour
Reported as:
Geometric least squares mean · units on a scale
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 125 mg LY3074828 Slow Versus Fast
units on a scalePart B: 125 mg LY3074828 (Test 4)Part B: 125 mg LY3074828 (Test 5)
Part B: Short Form McGill Pain Questionnaire (SF-MPQ) Total Score (Including VAS Score) For 125 mg LY3074828 Slow Versus Fast4.36 (3.00 to 6.35)3.07 (2.11 to 4.47)
Statistical analysis
  • Part B: 125 mg LY3074828 (Test 4) vs Part B: 125 mg LY3074828 (Test 5) · Ratio of geometric least squares mean: 0.70 · 90% CI 0.41 to 1.20

Adverse events

Collected over Baseline Up To Day 88. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Part A: 250 mg LY3074828 (Reference)0/18 (0%)0/18 (0%)2/18 (11.1%)
Part A: 250 mg LY3074828 (Test 1)0/18 (0%)0/18 (0%)6/18 (33.3%)
Part B: 250 mg LY3074828 (Test 2)0/18 (0%)0/18 (0%)1/18 (5.6%)
Part B: 250 mg LY3074828 (Test 3)0/18 (0%)0/18 (0%)5/18 (27.8%)
Part B: 125 mg LY3074828 (Test 4)0/18 (0%)0/18 (0%)1/18 (5.6%)
Part B: 125 mg LY3074828 (Test 5)0/18 (0%)0/18 (0%)1/18 (5.6%)
Most frequent other events
Showing 10 of 11
Most frequent other events
EventPart A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2)Part B: 250 mg LY3074828 (Test 3)Part B: 125 mg LY3074828 (Test 4)Part B: 125 mg LY3074828 (Test 5)
Injection site reactionGeneral disorders0/180/181/182/181/181/18
Ligament sprainInjury, poisoning and procedural complications0/182/180/180/180/180/18
DiarrhoeaGastrointestinal disorders0/180/180/181/180/180/18
Injection site bruisingGeneral disorders0/180/180/181/180/180/18
Upper respiratory tract infectionInfections and infestations0/181/180/180/180/180/18
Urinary tract infectionInfections and infestations0/181/180/180/180/180/18
Foot fractureInjury, poisoning and procedural complications0/181/180/180/180/180/18
HeadacheNervous system disorders0/181/180/180/180/180/18
CoughRespiratory, thoracic and mediastinal disorders1/181/180/180/180/180/18
Dermatitis contactSkin and subcutaneous tissue disorders0/180/180/181/180/180/18

Baseline characteristics

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

Age, Continuous
Age, Continuous(years)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)Total
Part A37.3 ± 12.733.9 ± 11.0NA ± NANA ± NA35.6 ± 11.8
Part BNA ± NANA ± NA42.1 ± 12.347.2 ± 12.344.7 ± 12.4
Sex: Female, Male
Sex: Female, Male(Participants)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)Total
Female9108633
Male98101239
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)Total
Hispanic or Latino623617
Not Hispanic or Latino1216151255
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)Total
American Indian or Alaska Native00000
Asian00112
Native Hawaiian or Other Pacific Islander00000
Black or African American876526
White1010101040
More than one race01023
Unknown or Not Reported00101
Region of Enrollment
Region of Enrollment(Participants)Part A: 250 mg LY3074828 (Reference)Part A: 250 mg LY3074828 (Test 1)Part B: 250 mg LY3074828 (Test 2 and Test 3)Part B: 125 mg LY3074828 (Test 4 and Test 5)Total
United States1818181872
07

Study locations

1 site
  • Covance
    Dallas, Texas 75247-4989, United States
08

References and documents

Study documents

  • Study protocol · Jul 26, 2018
  • Statistical analysis plan · Mar 19, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03456713
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 7, 2018
Start date
Mar 6, 2018
Primary completion
Aug 13, 2018
Completion
Aug 13, 2018
Results posted
Feb 20, 2024
Last update
Feb 20, 2024

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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