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| ID | Type | Description | Link |
|---|---|---|---|
| J4L-MC-KMAA | Other Identifier | Eli Lilly and Company |
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Based on emerging nonclinical data, the study was terminated.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: LY3872386 | Experimental | Single doses of LY3872386 (low dose, mid dose, and high dose) administered intravenously (IV) in healthy participants. |
|
| Part B: LY3872386 | Experimental | Part B was planned but not initiated as study terminated early due to emerging nonclinical data. |
|
| Part C: Prednisone | Experimental | Part C was planned but not initiated as study terminated early due to emerging nonclinical data. |
|
| Placebo | Placebo Comparator | Placebo administered IV in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY3872386 | Drug | Administered IV. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Baseline through Day 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386 | Cmax of LY3872386 is reported. | 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) |
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Inclusion Criteria:
Part A and C:
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
Part B:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | United States | ||
| Fortrea Clinical Research Unit |
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The study was designed to include three parts (A, B, and C). Results are reported only for Part A, as Parts B and C were not initiated and the study was terminated early due to emerging nonclinical data.
In Part A, single-ascending dose (SAD), of the LY3872386 (SAD Cohorts 1 and 2 and the sentinel pair in SAD Cohort 3,) was administered to healthy participants on Day 1, followed by a 12-week follow-up period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part A: Low Dose LY3872386 | Participants received a single low dose of LY3872386 administered IV in healthy participants. |
| FG001 | Part A: Mid-dose LY3872386 | Participants received a single mid-dose of LY3872386 administered IV in healthy participants. |
| FG002 | Part A: High Dose LY3872386 | Participants received a single high dose of LY3872386 administered IV in healthy participants. |
| FG003 | Part A: Placebo | Participants received placebo administered IV in healthy participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part A: Low Dose LY3872386 | Participants received a single low dose of LY3872386 administered IV in healthy participants. |
| BG001 | Part A: Mid-dose LY3872386 | Participants received a single mid-dose of LY3872386 administered IV in healthy participants. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All randomized participants who received at least one dose of study drug. | Posted | Number | participants | Baseline through Day 85 |
|
Baseline up to Day 85
All randomized participants who received at least one dose of the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part A: Low Dose LY3872386 | Participants received a single low dose of LY3872386 administered IV in healthy participants. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA 26.0 | Systematic Assessment |
Based on the emerging nonclinical data, Study KMAA was terminated after the dosing of participants in SAD Cohorts 1 and 2 (Dose 1 IV and Dose 2 IV) and the sentinel pair in SAD Cohort 3 (Dose 3 IV).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 08005455979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 10, 2023 | Jun 9, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 31, 2023 | Jun 9, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Part A, B are double blind and part C is open-label.
| Prednisone |
| Drug |
Administered orally. |
|
| Placebo | Drug | Administered IV. |
|
| 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. |
| 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. | 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. | Predose up to 12 hours post dose on day 14 and day 30 |
| Daytona Beach |
| Florida |
| 32117 |
| United States |
| BG002 | Part A: High Dose LY3872386 | Participants received a single high dose of LY3872386 administered IV in healthy participants. |
| BG003 | Part A: Placebo | Placebo administered IV in healthy participants. |
| BG004 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| OG001 | Part A: Mid-dose LY3872386 | Participants received a single mid-dose of LY3872386 administered IV in healthy participants. |
| OG002 | Part A: High Dose LY3872386 | Participants received a single high dose of LY3872386 administered IV in healthy participants. |
| OG003 | Part A: Placebo IV | Placebo administered IV in healthy participants. |
|
|
| Primary | 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. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part B. | Posted | Baseline through Day 183 |
|
|
| Primary | 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. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C. | Posted | Baseline through Day 44 |
|
|
| Secondary | Pharmacokinetics (PK): Part A and B: Maximum Observed Concentration (Cmax) of LY3872386 | Cmax of LY3872386 is reported. | All enrolled participants who received at least one dose of LY3872386 and had evaluable PK data in Part A. Zero participants were analyzed for Part B. Data were not captured as study was terminated early, and no participant were enrolled into Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (µg/mL) | 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) |
|
|
|
| Secondary | 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. | All enrolled participants who received at least one dose of LY3872386 and had evaluable PK data in Part A. Zero participants were analyzed for Part B. Data were not captured as study was terminated early, and no participant were enrolled into Part B. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram*hour per milliliter(µg*hr/mL) | 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) |
|
|
|
| Secondary | PK: Part C: Cmax of Prednisone and Prednisolone | Zero participants were analyzed in this outcome as study was terminated early. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C. | Posted | Predose up to 12 hours post dose on day 14 and day 30 |
|
|
| Secondary | PK: Part C: AUC of Prednisone and Prednisolone | Zero participants were analyzed in this outcome as study was terminated early. | Zero participants were analyzed for this outcome. Data were not captured as study was terminated early, and no participant were enrolled into Part C. | Posted | Predose up to 12 hours post dose on day 14 and day 30 |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 2 |
| 6 |
| EG001 | Part A: Mid-dose LY3872386 | Participants received a single mid-dose of LY3872386 administered IV in healthy participants. | 0 | 6 | 0 | 6 | 3 | 6 |
| EG002 | Part A: High Dose LY3872386 | Participants received a single high dose of LY3872386 administered IV in healthy participants. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Part A: Placebo | Participants received placebo administered IV in healthy participants. | 0 | 5 | 0 | 5 | 0 | 5 |
| Keratitis | Eye disorders | MedDRA 26.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 26.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
|
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| AUC(0-∞) of LY3872386 |
|