A Study of Different Injectable Formulations of LY3375880 in Healthy Participants

NCT03913260 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17212I9N-MC-FCAC
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (7)

Part A: LY3375880 Formulation A

EXPERIMENTAL

LY3375880 Formulation A administered subcutaneously (SC).

Drug: LY3375880; Device: Autoinjector (AI)

Part A: LY3375880 Formulation B

EXPERIMENTAL

LY3375880 Formulation B administered subcutaneously SC.

Drug: LY3375880; Device: Autoinjector (AI)

Part A: LY3375880 Formulation C

EXPERIMENTAL

LY3375880 Formulation C administered SC.

Drug: LY3375880; Device: Autoinjector (AI)

Part A: Positive Control

PLACEBO COMPARATOR

Positive Control (buffer matrix, only) administered SC.

Drug: Buffer Matrix (No LY3375880); Device: Autoinjector (AI)

Part B: LY3375880 Test 1

EXPERIMENTAL

LY3375880 Test 1 Formulation administered SC.

Drug: LY3375880; Device: Manual Syringe

Part B: LY3375880 Test 2

EXPERIMENTAL

LY3375880 Test 2 Formulation administered SC.

Drug: LY3375880; Device: Manual Syringe

Part B: LY3375880 Test 3

EXPERIMENTAL

LY3375880 Test 3 Formulation administered SC.

Drug: LY3375880; Device: Manual Syringe

Interventions

LY3375880 DRUG

Administered SC

Part A: LY3375880 Formulation A; Part A: LY3375880 Formulation B; Part A: LY3375880 Formulation C; Part B: LY3375880 Test 1; Part B: LY3375880 Test 2; Part B: LY3375880 Test 3

Buffer Matrix (No LY3375880) DRUG

Administered SC

Part A: Positive Control

Autoinjector (AI) DEVICE

AI used to administer LY3375880 or Buffer Matrix

Part A: LY3375880 Formulation A; Part A: LY3375880 Formulation B; Part A: LY3375880 Formulation C; Part A: Positive Control

Manual Syringe DEVICE

Manual syringe used to inject LY3375880

Part B: LY3375880 Test 1; Part B: LY3375880 Test 2; Part B: LY3375880 Test 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

Covance

Dallas, Texas, 75247, United States

Location

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part A is a crossover design. Part B is a parallel design.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 12, 2019
• Study Start: May 1, 2019
• Primary Completion: September 19, 2019
• Study Completion: September 19, 2019
• Last Updated: October 11, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)