A Study of LY3375880 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT03343587

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: LY3375880 IV Drug: LY3375880 SC Drug: Placebo IV Drug: Placebo SC	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3375880 in Healthy Subjects

Actual Study Start Date :

Nov 17, 2017

Actual Primary Completion Date :

Nov 16, 2018

Actual Study Completion Date :

Nov 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3375880 Single Dose Single dose of LY3375880 administered IV or SC	Drug: LY3375880 IV administered IV Drug: LY3375880 SC administered SC
Placebo Comparator: Placebo Single Dose Single dose of placebo administered IV or SC	Drug: Placebo IV administered IV Drug: Placebo SC administered SC
Experimental: LY3375880 Multiple Dose Multiple doses of LY3375880 administered IV or SC	Drug: LY3375880 IV administered IV Drug: LY3375880 SC administered SC
Placebo Comparator: Placebo Multiple Dose Multiple doses of placebo administered IV or SC	Drug: Placebo IV administered IV Drug: Placebo SC administered SC

Outcome Measures

Primary Outcome Measures

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Pre-dose to 3 months after administration of study drug]
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880 [Pre-dose to 3 months after administration of study drug]
PK: Cmax of LY3375880
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880 [Pre-dose to 3 months after administration of study drug]
PK: AUC of LY3375880

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel Early Phase Unit at Glendale	Glendale	California	United States	91206

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director: 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT03343587

Other Study ID Numbers:

16833
I9N-MC-FCAA

First Posted:

Nov 17, 2017

Last Update Posted:

Dec 10, 2018

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Dec 10, 2018