A Study of LY3375880 in Healthy Participants

December 7, 2018 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Glendale, California, United States, 91206
        • Parexel Early Phase Unit at Glendale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: 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
Pre-dose to 3 months after administration of study drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880
Time Frame: Pre-dose to 3 months after administration of study drug
PK: 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
Time Frame: Pre-dose to 3 months after administration of study drug
PK: AUC of LY3375880
Pre-dose to 3 months after administration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 17, 2017

Primary Completion (ACTUAL)

November 16, 2018

Study Completion (ACTUAL)

November 16, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 13, 2017

First Posted (ACTUAL)

November 17, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 10, 2018

Last Update Submitted That Met QC Criteria

December 7, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 16833
  • I9N-MC-FCAA (OTHER: Eli Lilly and Company)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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