A Study of LY3375880 in Healthy Participants

NCT03343587 | Completed Phase 1 FDA Drug

• 2 other identifiers: 16833I9N-MC-FCAA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm. This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Pre-dose to 3 months after administration of study drug

Secondary Outcomes (2)

• Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880

  Pre-dose to 3 months after administration of study drug

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880

  Pre-dose to 3 months after administration of study drug

Study Arms (4)

LY3375880 Single Dose

EXPERIMENTAL

Single dose of LY3375880 administered IV or SC

Drug: LY3375880 IV; Drug: LY3375880 SC

Placebo Single Dose

PLACEBO COMPARATOR

Single dose of placebo administered IV or SC

Drug: Placebo IV; Drug: Placebo SC

LY3375880 Multiple Dose

EXPERIMENTAL

Multiple doses of LY3375880 administered IV or SC

Drug: LY3375880 IV; Drug: LY3375880 SC

Placebo Multiple Dose

PLACEBO COMPARATOR

Multiple doses of placebo administered IV or SC

Drug: Placebo IV; Drug: Placebo SC

Interventions

LY3375880 IV DRUG

administered IV

LY3375880 Multiple Dose; LY3375880 Single Dose

LY3375880 SC DRUG

administered SC

LY3375880 Multiple Dose; LY3375880 Single Dose

Placebo IV DRUG

administered IV

Placebo Multiple Dose; Placebo Single Dose

Placebo SC DRUG

administered SC

Placebo Multiple Dose; Placebo Single Dose

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
• 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
• Are women who are of childbearing potential or who are lactating

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 17, 2017
• Study Start: November 17, 2017
• Primary Completion: November 16, 2018
• Study Completion: November 16, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12-01

Locations

US (1)