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

Lilly

Status and phase: Terminated; Phase 1

Conditions: Atopic Dermatitis; Healthy

Treatments: Drug: LY3872386; Drug: Placebo; Drug: Prednisone

Study type: Interventional

Funder types: Industry

Identifiers

NCT06119529

18607

J4L-MC-KMAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

18 participants in 4 patient groups, including a placebo group

Part A: LY3872386

Experimental group

Description:

Single doses of LY3872386 administered either intravenously (IV) or subcutaneously (SC) in healthy participants.

Treatment:

Drug: LY3872386

Part B: LY3872386

Experimental group

Description:

Multiple doses of LY3872386 administered either IV or SC in participants with atopic dermatitis.

Treatment:

Drug: LY3872386

Part C: Prednisone

Experimental group

Description:

Prednisone administered orally in healthy participants.

Treatment:

Drug: Prednisone

Placebo

Placebo Comparator group

Description:

Placebo administered either IV or SC.

Treatment:

Drug: Placebo