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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03913260

Enrollment

Registered

2019-04-12

Start date

2019-05-01

Completion date

2019-09-19

Last updated

2019-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DRUGLY3375880

Administered SC

DRUGBuffer Matrix (No LY3375880)

Administered SC

DEVICEAutoinjector (AI)

AI used to administer LY3375880 or Buffer Matrix

DEVICEManual Syringe

Manual syringe used to inject LY3375880

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Intervention model description

Part A is a crossover design. Part B is a parallel design.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880	Part B: Predose through Day 85	PK: AUC of LY3375880

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026