A Study of LY3200327 in Healthy Participants

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3200327 (IV); Drug: Placebo (SC); Drug: Placebo (IV); Drug: LY3200327 (SC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02595736

I8C-MC-GSFA (Other Identifier)

15577

Details and patient eligibility

About

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).

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 4 patient groups, including a placebo group

Placebo (SC)

Placebo Comparator group

Description:

Single subcutaneous (SC) dose of placebo

Treatment:

Drug: Placebo (SC)

LY3200327 (SC)

Experimental group

Description:

Single escalating subcutaneous (SC) dose of LY3200327

Treatment:

Drug: LY3200327 (SC)

LY3200327 (IV)

Experimental group

Description:

Single intravenous (IV) dose of LY3200327

Treatment:

Drug: LY3200327 (IV)

Placebo (IV)

Placebo Comparator group

Description:

Single intravenous (IV) dose of placebo

Treatment:

Drug: Placebo (IV)