Clinical trial NCT06119529: A Study of LY3872386 in Healthy Participants and Participants With Atopic Dermatitis
Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3872386 in Healthy Participants, a Multiple-Ascending Dose Study of LY3872386 in Patients With Atopic Dermatitis, and an Open-Label Multiple-Dose Evaluation of the Safety and Tolerability of Prednisone in Healthy Participants.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Atopic Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Part A: Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs) and other non-serious adverse events (AEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 85
measure: Part B: Number of Participants with One or More TEAEs, SAEs and other non-serious AEs Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 183
measure: Part C: Number of Participants with One or More TEAEs, SAEs and other non-serious AEs Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline through Day 44
Secondary outcomes:
measure: Part A and B: Maximum Observed Concentration (Cmax) of LY3872386
timeFrame: Predose up to 85 days (Part A) and 183 days (Part B)
measure: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386
timeFrame: Predose up to 85 days (Part A) and 183 days (Part B)
measure: Part C: Cmax of Prednisone and Prednisolone
timeFrame: Predose up to 12 hours post dose on day 14 and day 30
measure: Part C: AUC of Prednisone and Prednisolone
timeFrame: Predose up to 12 hours post dose on day 14 and day 30
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CenExel ACT
state: California
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: