A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3375880; Drug: Buffer Matrix (No LY3375880); Device: Autoinjector (AI); Device: Manual Syringe

• Registration Number: NCT03913260
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-04-11
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Study Start: 2019-05-01
• Primary Completion: 2019-09-19
• Study Completion: 2019-09-19
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-09
• Last Update Posted: 2019-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part B: LY3375880 Test 2	LY3375880	LY3375880 Test 2 Formulation administered SC.
Part A: Positive Control	Autoinjector (AI)	Positive Control (buffer matrix, only) administered SC.
Part B: LY3375880 Test 1	LY3375880	LY3375880 Test 1 Formulation administered SC.
Part A: LY3375880 Formulation A	LY3375880	LY3375880 Formulation A administered subcutaneously (SC).
Part A: LY3375880 Formulation A	Autoinjector (AI)	LY3375880 Formulation A administered subcutaneously (SC).
Part A: LY3375880 Formulation B	LY3375880	LY3375880 Formulation B administered subcutaneously SC.
Part A: LY3375880 Formulation B	Autoinjector (AI)	LY3375880 Formulation B administered subcutaneously SC.
Part A: LY3375880 Formulation C	LY3375880	LY3375880 Formulation C administered SC.
Part A: LY3375880 Formulation C	Autoinjector (AI)	LY3375880 Formulation C administered SC.
Part A: Positive Control	Buffer Matrix (No LY3375880)	Positive Control (buffer matrix, only) administered SC.
Part B: LY3375880 Test 1	Manual Syringe	LY3375880 Test 1 Formulation administered SC.
Part B: LY3375880 Test 2	Manual Syringe	LY3375880 Test 2 Formulation administered SC.
Part B: LY3375880 Test 3	LY3375880	LY3375880 Test 3 Formulation administered SC.
Part B: LY3375880 Test 3	Manual Syringe	LY3375880 Test 3 Formulation administered SC.

Primary Outcome Measures

Name	Time	Method
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880	Part B: Predose through Day 85	PK: AUC of LY3375880
Visual Analog Scale (VAS) Pain Score	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	Part B: Predose through Day 85	PK: Cmax of LY3375880

Trial Locations

Locations (2)

Covance; 🇺🇸 Dallas, Texas, United States

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States