A Study of LY3200327 in Healthy Participants

A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3200327 in Healthy Subjects

The purpose of this study is to look at the safety and tolerability of single doses of LY3200327 when given to healthy male and female participants either by injection under the skin or by drip into a vein. The study will help determine how the drug behaves inside the body and how long it takes to disappear from the body. The study will also look for anti-drug antibodies and how these may affect how LY3200327 acts in your body.

The study is expected to last approximately 12 weeks (with screening evaluations up to 4 weeks prior).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo (SC); Drug: LY3200327 (SC); Drug: LY3200327 (IV); Drug: Placebo (IV)

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Parexel International/ California Clinical Trials

Participation Criteria

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:

• At the time of initial screening, in general good health
• First-generation healthy Japanese (age 20 to 65 years) will be included

Exclusion Criteria:

• Pregnancy or breastfeeding during the study
• Chronic infection
• Treatment with prohibited medications

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo (SC); Single subcutaneous (SC) dose of placebo	Drug: Placebo (SC); Administered SC
Experimental: LY3200327 (SC); Single escalating subcutaneous (SC) dose of LY3200327	Drug: LY3200327 (SC); Administered SC
Experimental: LY3200327 (IV); Single intravenous (IV) dose of LY3200327	Drug: LY3200327 (IV); Administered IV
Placebo Comparator: Placebo (IV); Single intravenous (IV) dose of placebo	Drug: Placebo (IV); Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	Baseline to study completion (approximately 12 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327	Pre-dose up to 84 days post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327	Pre-dose up to 84 days post dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: November 2, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Estimate): September 12, 2016
• Last Update Submitted That Met QC Criteria: September 9, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 15577; I8C-MC-GSFA (Other Identifier: Eli Lilly and Company)