A Study of LY3375880 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo IV; Drug: LY3375880 IV; Drug: Placebo SC; Drug: LY3375880 SC

• Registration Number: NCT03343587
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study Start: 2017-11-17
• Study First Posted: 2017-11-17
• Primary Completion: 2018-11-16
• Study Completion: 2018-11-16
• Status Verified: 2018-12-01
• Last Update Submitted: 2018-12-07
• Last Update Posted: 2018-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Multiple Dose	Placebo IV	Multiple doses of placebo administered IV or SC
Placebo Multiple Dose	Placebo SC	Multiple doses of placebo administered IV or SC
LY3375880 Single Dose	LY3375880 SC	Single dose of LY3375880 administered IV or SC
LY3375880 Multiple Dose	LY3375880 SC	Multiple doses of LY3375880 administered IV or SC
Placebo Single Dose	Placebo SC	Single dose of placebo administered IV or SC
LY3375880 Multiple Dose	LY3375880 IV	Multiple doses of LY3375880 administered IV or SC
LY3375880 Single Dose	LY3375880 IV	Single dose of LY3375880 administered IV or SC
Placebo Single Dose	Placebo IV	Single dose of placebo administered IV or SC

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel Early Phase Unit at Glendale; 🇺🇸 Glendale, California, United States