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OpenTrials
Completed

NCT Number: NCT02595736

A Study of LY3200327 in Healthy Participants

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).

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International/ California Clinical Trials

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo (SC)

Drug

Administered SC

LY3200327 (SC)

Drug

Administered SC

LY3200327 (IV)

Drug

Administered IV

Placebo (IV)

Drug

Administered IV

Primary outcomes

  1. 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: Baseline to study completion (approximately 12 weeks)

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3200327

    Time frame: Pre-dose up to 84 days post dose

  2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3200327

    Time frame: Pre-dose up to 84 days post dose

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 3, 2015
Registry last updated
Sep 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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