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.
Trial 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. Read more about this study
- 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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06119529
- Acronym / sponsor ID
- 18607
- Conditions
- Healthy, Atopic Dermatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Based on emerging nonclinical data, the study was terminated.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Posted 3 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A: LY3872386 | Experimental | Drug: LY3872386Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants. |
| Part B: LY3872386 | Experimental | Drug: LY3872386Part B was planned but not initiated as study terminated early due to emerging nonclinical data. |
| Part C: Prednisone | Experimental | Drug: PrednisonePart C was planned but not initiated as study terminated early due to emerging nonclinical data. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered IV in healthy participants. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Overtly healthy as determined by medical evaluation
- 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
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3872386Administered IV. | Drug | Part A: LY3872386, Part B: LY3872386 |
| PrednisoneAdministered orally. | Drug | Part C: Prednisone |
| PlaceboAdministered IV. | Drug | Placebo |
Primary outcome
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
Time frame: Baseline through Day 85
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.
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
Time frame: Baseline through Day 183
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.
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
Time frame: Baseline through Day 44
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.
4 secondary outcomes
Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386
Time frame: 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
Time frame: 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
Time frame: Predose up to 12 hours post dose on day 14 and day 30
PK: Part C: AUC of Prednisone and Prednisolone
Time frame: Predose up to 12 hours post dose on day 14 and day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Baseline through Day 85). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.