A Study of LY3200327 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo (SC); Drug: LY3200327 (SC); Drug: LY3200327 (IV); Drug: Placebo (IV)

• Registration Number: NCT02595736
• Lead Sponsor: Eli Lilly and Company

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-09
• Last Update Posted: 2016-09-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (SC)	Placebo (SC)	Single subcutaneous (SC) dose of placebo
LY3200327 (SC)	LY3200327 (SC)	Single escalating subcutaneous (SC) dose of LY3200327
LY3200327 (IV)	LY3200327 (IV)	Single intravenous (IV) dose of LY3200327
Placebo (IV)	Placebo (IV)	Single intravenous (IV) dose of placebo

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	Baseline to study completion (approximately 12 weeks)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Parexel International/ California Clinical Trials; 🇺🇸 Glendale, California, United States