A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

A Safety, Tolerability, and Pharmacokinetic Study of Different Solution Formulations of LY3375880 Using Investigational Injection Devices in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY3375880; Device: Autoinjector (AI); Drug: Buffer Matrix (No LY3375880); Device: Manual Syringe

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc
  • Texas
    • Dallas, Texas, United States, 75247
      • Covance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Part A: LY3375880 Formulation A; LY3375880 Formulation A administered subcutaneously (SC).	Drug: LY3375880; Administered SC; Device: Autoinjector (AI); AI used to administer LY3375880 or Buffer Matrix
EXPERIMENTAL: Part A: LY3375880 Formulation B; LY3375880 Formulation B administered subcutaneously SC.	Drug: LY3375880; Administered SC; Device: Autoinjector (AI); AI used to administer LY3375880 or Buffer Matrix
EXPERIMENTAL: Part A: LY3375880 Formulation C; LY3375880 Formulation C administered SC.	Drug: LY3375880; Administered SC; Device: Autoinjector (AI); AI used to administer LY3375880 or Buffer Matrix
PLACEBO_COMPARATOR: Part A: Positive Control; Positive Control (buffer matrix, only) administered SC.	Device: Autoinjector (AI); AI used to administer LY3375880 or Buffer Matrix; Drug: Buffer Matrix (No LY3375880); Administered SC
EXPERIMENTAL: Part B: LY3375880 Test 1; LY3375880 Test 1 Formulation administered SC.	Drug: LY3375880; Administered SC; Device: Manual Syringe; Manual syringe used to inject LY3375880
EXPERIMENTAL: Part B: LY3375880 Test 2; LY3375880 Test 2 Formulation administered SC.	Drug: LY3375880; Administered SC; Device: Manual Syringe; Manual syringe used to inject LY3375880
EXPERIMENTAL: Part B: LY3375880 Test 3; LY3375880 Test 3 Formulation administered SC.	Drug: LY3375880; Administered SC; Device: Manual Syringe; Manual syringe used to inject LY3375880

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Pain Score	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).	Part A: Within 1-minute post injection
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880	PK: Cmax of LY3375880	Part B: Predose through Day 85
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880	PK: AUC of LY3375880	Part B: Predose through Day 85

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): September 19, 2019
• Study Completion (ACTUAL): September 19, 2019

Study Registration Dates

• First Submitted: April 11, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (ACTUAL): April 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 11, 2019
• Last Update Submitted That Met QC Criteria: October 9, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 17212 (Other Identifier: City of Hope Comprehensive Cancer Center); I9N-MC-FCAC (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes