HealthyPhase 1NCT06119529

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

A Phase 1 study testing LY3872386 and Prednisone in people with Healthy and Atopic Dermatitis, run by Eli Lilly and Company at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Atopic Dermatitis
What is being tested?: LY3872386 and Prednisone
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 18 participants
Where: 2 sitesUnited States
Study dates: 1 Nov 2023to 8 Apr 2024
Phase: Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Part A and C:
Overtly healthy as determined by medical evaluation
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
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

Show all 11Show fewer

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

Who cannot join

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 locations and contacts

2 sites in 1 country.

United States2 sites

CenExel ACT
Anaheim, California, 92801
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117

Other trials in United States

About this study

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.

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.

Conditions: Healthy, Atopic Dermatitis
Being tested: LY3872386, Prednisone, Placebo
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY3872386Drug
Administered IV.
PrednisoneDrug
Administered orally.
PlaceboDrug
Administered IV.

Study groups in NCT06119529
Study group	Role	What they receive
Part A: LY3872386	Experimental	Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants. Receives: Drug: LY3872386
Part B: LY3872386	Experimental	Part B was planned but not initiated as study terminated early due to emerging nonclinical data. Receives: Drug: LY3872386
Part C: Prednisone	Experimental	Part C was planned but not initiated as study terminated early due to emerging nonclinical data. Receives: Drug: Prednisone
Placebo	Placebo comparator	Placebo administered IV in healthy participants. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug.
Measured: Baseline through Day 85
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
Measured: Baseline through Day 183
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is located in the Reported Adverse Event module. Drug related TEAEs are any untoward medical occurrences that either occurs postdose or presents prior to dosing yet becomes more severe postdose, and in the opinion of the investigator is possibly related to study drug. Zero participants were analyzed in this outcome as study was terminated early.
Measured: Baseline through Day 44

Secondary outcomes (4)

Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386
Cmax of LY3872386 is reported.
Measured: Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)
PK: Part A and B: Area Under the Concentration Versus Time Curve (AUC) of LY3872386
Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) and Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3872386 is reported.
Measured: Day 1: predose, end of infusion, 3 hours, 6 hours, and 12 hours postdose, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose (Part A)
PK: Part C: Cmax of Prednisone and Prednisolone
Zero participants were analyzed in this outcome as study was terminated early.
Measured: Predose up to 12 hours post dose on day 14 and day 30
PK: Part C: AUC of Prednisone and Prednisolone
Zero participants were analyzed in this outcome as study was terminated early.
Measured: Predose up to 12 hours post dose on day 14 and day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 20238 Apr 2024

First posted7 Nov 2023
Study start1 Nov 2023
Primary completion8 Apr 2024
Study completion8 Apr 2024

Why it stopped: Based on emerging nonclinical data, the study was terminated.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06119529
Sponsor's protocol ID: 18607
Other IDs: J4L-MC-KMAA
Status last verified: Sep 2025
First submitted: 1 Nov 2023
Last updated: 3 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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