Phase 1
N=66
A Study of Injections of LY3074828 in Healthy Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03886948 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 — 9.19; 8.19 microgram/milliliter (ug/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3074828 (Drug); Pre-filled syringe (PFS) (Device); Autoinjector (AI) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828 |
9.19; 8.19 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration |
146; 130 | — |
| PRIMARY PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828 |
149; 133 | — |
| PRIMARY Visual Analog Scale (VAS) Pain Score by Device |
27.2; 22.9; 8.3; 10.9; 2.3; 2.8 | — |
| PRIMARY Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location |
30.1; 27.4; 24.1; 26.7; 22.5; 19.5 | — |
Summary
The purpose of this study is to learn about the effects of LY3074828 when given as an injection just under the skin by two different devices. The study will last about 12 weeks for each participant.
Eligibility Criteria
Inclusion Criteria
- Must be healthy males or females
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 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
- 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
Data sourced from ClinicalTrials.gov (NCT03886948). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.