A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Manual Syringe
- Conditions
- Healthy
- Sponsor
- Eli Lilly and Company
- Enrollment
- 83
- Locations
- 2
- Primary Endpoint
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Are overtly healthy males or females, as determined by medical history and physical examination
- •Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- •Females who are not of child-bearing potential
- •Males who agree to use a reliable method of birth control during the study and for 120 days following the final administration of LY3375880
- •Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria
- •Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- •Have participated or are currently enrolled in clinical trials with LY3375880
- •Have infections or evidence of infections
- •Are pregnant, lactating or breast feeding
Arms & Interventions
Part B: LY3375880 Test 3
LY3375880 Test 3 Formulation administered SC.
Intervention: Manual Syringe
Part B: LY3375880 Test 3
LY3375880 Test 3 Formulation administered SC.
Intervention: LY3375880
Part A: LY3375880 Formulation A
LY3375880 Formulation A administered subcutaneously (SC).
Intervention: LY3375880
Part A: LY3375880 Formulation A
LY3375880 Formulation A administered subcutaneously (SC).
Intervention: Autoinjector (AI)
Part A: LY3375880 Formulation B
LY3375880 Formulation B administered subcutaneously SC.
Intervention: LY3375880
Part A: LY3375880 Formulation B
LY3375880 Formulation B administered subcutaneously SC.
Intervention: Autoinjector (AI)
Part A: LY3375880 Formulation C
LY3375880 Formulation C administered SC.
Intervention: LY3375880
Part A: LY3375880 Formulation C
LY3375880 Formulation C administered SC.
Intervention: Autoinjector (AI)
Part A: Positive Control
Positive Control (buffer matrix, only) administered SC.
Intervention: Buffer Matrix (No LY3375880)
Part A: Positive Control
Positive Control (buffer matrix, only) administered SC.
Intervention: Autoinjector (AI)
Part B: LY3375880 Test 1
LY3375880 Test 1 Formulation administered SC.
Intervention: LY3375880
Part B: LY3375880 Test 1
LY3375880 Test 1 Formulation administered SC.
Intervention: Manual Syringe
Part B: LY3375880 Test 2
LY3375880 Test 2 Formulation administered SC.
Intervention: LY3375880
Part B: LY3375880 Test 2
LY3375880 Test 2 Formulation administered SC.
Intervention: Manual Syringe
Outcomes
Primary Outcomes
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
Time Frame: Part B: Predose through Day 85
PK: AUC of LY3375880
Visual Analog Scale (VAS) Pain Score
Time Frame: Part A: Within 1-minute post injection
The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
Time Frame: Part B: Predose through Day 85
PK: Cmax of LY3375880