A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-04-08

Brief Summary

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The main purpose of this study is to evaluate the safety and tolerability of LY3872386 in healthy participants and participants with atopic dermatitis. The safety of prednisone is also evaluated in healthy participants. Blood tests will be performed to investigate how the body processes the LY3872386 following single and multiple dosing in healthy participants and participants with atopic dermatitis. Blood tests will also be performed to investigate how the body processes the prednisone in healthy participants. The study is conducted in three parts (part A, B and C). The study will last up to approximately 85, 183 and 44 days for parts A, B, and C, respectively.

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Detailed Description

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Conditions

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Healthy Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Part A, B are double blind and part C is open-label.

Study Groups

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Part A: LY3872386

Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants.

Group Type EXPERIMENTAL

LY3872386

Intervention Type DRUG

Administered IV.

Part B: LY3872386

Part B was planned but not initiated as study terminated early due to emerging nonclinical data.

Group Type EXPERIMENTAL

LY3872386

Intervention Type DRUG

Administered IV.

Part C: Prednisone

Part C was planned but not initiated as study terminated early due to emerging nonclinical data.

Group Type EXPERIMENTAL

Prednisone

Intervention Type DRUG

Administered orally.

Placebo

Placebo administered IV in healthy participants.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV.

Interventions

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LY3872386

Administered IV.

Intervention Type DRUG

Prednisone

Administered orally.

Intervention Type DRUG

Placebo

Administered IV.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Part A and C:

* Overtly healthy as determined by medical evaluation

1. To qualify as Japanese for the purpose of this study, the participant must be first generation Japanese, defined as the participant's biological parents and all of the participant's biological grandparents must be of exclusive Japanese descent, and must have been born in Japan
2. To qualify as Chinese for the purpose of this study, the participant must be, at a minimum, third-generation Chinese, defined as all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
* Have a body mass index of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male participants who agree to use highly effective or effective methods of contraception and women not of childbearing potential may participate in part A and C

Part B:

* Participants who have a diagnosis of atopic dermatitis at least 12 months prior to screening as defined by the American Academy of Dermatology
* Have a history, documented by a physician and/or investigator, of inadequate response to existing topical medications within 6 months preceding screening, or participants who failed systemic therapies intended to treat atopic dermatitis or a history of intolerance to topical therapy
* Have a body mass index of 18.0 to 38.0 kilograms per square meter (kg/m²), inclusive
* Male participants who agree to use highly effective or effective methods of contraception, women not of childbearing potential and women of childbearing potential may participate in part B

Exclusion Criteria

* Women who are pregnant and/or lactating
* Participants who have received live vaccine(s) (including attenuated live vaccines) or Bacillus Calmette- Guérin within 35 days of screening
* Have a history or presence of multiple or severe allergies or an anaphylactic reaction to prescription or nonprescription drugs
* Have a known history of diabetes
* Have fasting glucose level of ≥126 milligrams per deciliter (mg/dL) and glycated hemoglobin ≥6.5 percent (%) and/or taking anti-diabetes medications at screening
* Have known history of osteoporosis

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes