A Study of LY3200327 in Healthy Participants

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02595736

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Placebo (SC) Drug: LY3200327 (SC) Drug: LY3200327 (IV) Drug: Placebo (IV)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Nov 1, 2015

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Aug 1, 2016

Arms and Interventions

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

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 [Baseline to study completion (approximately 12 weeks)]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Parexel International/ California Clinical Trials	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:

NCT02595736

Other Study ID Numbers:

15577
I8C-MC-GSFA

First Posted:

Nov 3, 2015

Last Update Posted:

Sep 12, 2016

Last Verified:

Sep 1, 2016

Study Results

No Results Posted as of Sep 12, 2016