HealthyPhase 1NCT05486208
A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis
A Phase 1 study testing LY3844583 in people with Healthy and Dermatitis, Atopic, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD). The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Dermatitis, Atopic
- What is being tested?
- LY3844583
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Aug 2022to 20 Jan 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
- Healthy participants (Parts A and B):
- Are male or female not of childbearing potential
- Inclusion of healthy Japanese participants, 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.
- Inclusion of healthy Chinese participants, the participant must be at a minimum, third-generation Chinese, defined as all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China.
- Must have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive. For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m², inclusive, and a body weight of 50 kg to 85 kg, inclusive.
- Atopic dermatitis participants (Part C):
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- Must have a body mass index of 18.0 to 45.0 kg/m², inclusive
- Are male or female participants including those of child bearing potential
- Must have a diagnosis of AtD for at least 12 months with either poor response to topical treatments or inability to use topical treatments
- Must agree to use moisturizer daily throughout the treatment period
Who cannot join
- All participants:
- Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
- Have active or latent tuberculosis
- Have had any cancer within the past 5 years. Exceptions: successfully treated basal cell skin carcinoma or squamous cell skin carcinoma, with no evidence of recurrence or metastatic disease within the 3 years prior to baseline
- Have one of the following viral infections: hepatitis B virus, hepatitis C virus or human immunodeficiency virus.
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 30 days or 5 half-lives (whichever is longer) prior to dosing
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- Must not have previously completed a clinical trial with a molecule targeting interleukin-33 and/or the interleukin-33 receptor (ST2)
- Are currently participating in or completed a clinical trial within the last 30 days
- Have received a vaccine containing a live (attenuated) virus within 28 days of screening or intend to receive during the course of the study
- Atopic dermatitis participants:
- Must not have received certain topical medications for AtD within 2 weeks prior to randomization
- Must not have received certain oral medications for AtD or received phototherapy within 4 weeks prior to randomization
- Must not have received any antibody-based biologic agents (marketed or investigational) within 5 half lives (t1/2) of the drug prior to randomization
- Must not have received intravenous, intramuscular, or intra-articular steroids in the past 6 weeks prior to randomization
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Japan2 sites
P-one clinic
Hachiōji, Tokyo, 192-0071
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
United States1 site
Parexel Early Phase Unit at Glendale
Glendale, California, 91206-4140
About this study
Official title: A Phase 1, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending Dose Study of LY3844583 in Healthy Participants, and Multiple-Dose Study of LY3844583 in Healthy Participants and Patients With Atopic Dermatitis
The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis (AtD). The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis. The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 85, 113, and 183 days with 10, 18, and 14 visits for each participant in parts A, B, and C, respectively.
- Conditions
- Healthy, Dermatitis, Atopic
- Being tested
- LY3844583, 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.
LY3844583Drug
Administered SC
LY3844583Drug
Administered IV
PlaceboDrug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: Placebo SC (Single Ascending Dose [SAD] - Cohort 1-3) | Placebo comparator | Healthy participants received a single matching dose of Placebo via subcutaneous (SC) injection on Day 1. Receives: Drug: Placebo |
| Part A: Placebo IV (SAD - Cohort 4-5) | Placebo comparator | Healthy participants received a single matching dose of Placebo via intravenous (IV) infusion on Day 1. Receives: Drug: Placebo |
| Part A: 30 mg LY3844583 SC (SAD - Cohort 1) | Experimental | Healthy participants received a single dose of 30 milligrams (mg) LY3844583 via SC injection on Day 1. Receives: Drug: LY3844583 |
| Part A: 100 mg LY3844583 SC (SAD - Cohort 2) | Experimental | Healthy participants received a single dose of 100 mg LY3844583 via SC injection on Day 1. Receives: Drug: LY3844583 |
| Part A: 300 mg LY3844583 SC (SAD - Cohort 3) | Experimental | Healthy participants received a single dose of 300 mg LY3844583 via SC injection on Day 1. Receives: Drug: LY3844583 |
| Part A: 300 mg LY3844583 IV (SAD - Cohort 4) | Experimental | Healthy participants received a single dose of 300 mg LY3844583 via IV infusion on Day 1. Receives: Drug: LY3844583 |
| Part A: 1000 mg LY3844583 IV (SAD - Cohort 5) | Experimental | Healthy participants received a single dose of 1000 mg LY3844583 via IV infusion on Day 1. Receives: Drug: LY3844583 |
| Part B: Placebo IV (Multiple Ascending Dose [MAD] - Cohort 1-2) | Experimental | Healthy participants received a matching dose of Placebo via IV infusion once every 2 weeks (Q2W) on Days 1, 15, and 29 in Cohort 1, or once every week (QW) on Days 1, 8, 15, 22, and 29 in Cohort 2. Receives: Drug: Placebo |
| Part B: 300 mg LY3844583 IV Q2W (MAD - Cohort 1) | Experimental | Healthy participants received 300 mg LY3844583 via IV infusion Q2W on Days 1, 15, and 29. Receives: Drug: LY3844583 |
| Part B: 1000 mg LY3844583 IV QW (MAD - Cohort 2) | Experimental | Healthy participants received 1000 mg LY3844583 via IV infusion QW on Days 1, 8, 15, 22, and 29. Receives: Drug: LY3844583 |
| Part C: Placebo IV Q2W | Experimental | Participants with Atopic Dermatitis (AtD) received a matching dose of Placebo via IV infusion Q2W for 12 weeks. Receives: Drug: Placebo |
| Part C: 1000 mg LY3844583 IV Q2W (Cohort 1) | Experimental | Participants with AtD received 1000 mg LY3844583 via IV infusion Q2W for 12 weeks. Receives: Drug: LY3844583 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With One or More Adverse Events (AEs) - Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
- An AE was any untoward medical occurrence in a participant who was administered an investigational product that did not necessarily have a causal relationship with the treatment. A TEAE was defined as an AE that occurred post-dose or was present prior to dosing and became more severe post-dose.
- An SAE was any AE from the study that resulted in one of the following: death, initial or prolonged inpatient hospitalization, a life-threatening experience (i.e., immediate risk of dying), persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that might not have been immediately life-threatening or resulted in death or hospitalization but might have jeopardized the participant or required intervention to prevent one of the other outcomes listed in the definition above.
- A summary of SAEs and other non-serious AEs, regardless of causality, is located in the reported Adverse Events section of this record.
Measured: Part A: Baseline to Follow-Up (Up to 85 Days); Part B: Baseline to Follow-Up (Up to 113 Days); Part C: Baseline to Follow-Up (Up to 183 Days)
Secondary outcomes (8)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3844583 - Part A (SAD)
PK: Cmax of LY3844583 in Part A (SAD)
Measured: Part A (SAD): Day 1 (Predose, end of infusion (IV route Cohorts 4 and 5 only), 3, 6, 12, 24, 48, 72, 96, 120, 144, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hours postdose)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-inf]) of LY3844583 - Part A (SAD)
PK: AUC(0-inf) of LY3844583 in Part A (SAD)
Measured: Part A (SAD): Day 1 (Predose, end of infusion (IV route Cohorts 4 and 5 only), 3, 6, 12, 24, 48, 72, 96, 120, 144, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hours postdose)
PK: Cmax of LY3844583 - Part B (MAD - Cohort 1)
PK: Cmax of LY3844583 in Part B (MAD - Cohort 1)
Measured: Part B (MAD - Cohort 1): Day 1 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 240, 336 hours postdose); Day 29 (predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 240, 336, 672, 1344, 1848, 2016 hours postdose)
PK: Area Under the Concentration Versus Time Curve During One Dosing Interval (AUCτ) of LY3844583 - Part B (MAD - Cohort 1)
PK: AUCτ of LY3844583 (τ = 336 hrs) in Part B (MAD - Cohort 1)
Measured: Part B (MAD - Cohort 1): Day 1 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 240, 336 hours postdose); Day 29 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 240, 336 hours postdose)
PK: Cmax of LY3844583 - Part B (MAD - Cohort 2)
PK: Cmax of LY3844583 in Part B (MAD - Cohort 2)
Measured: Part B (MAD - Cohort 2): Day 1 (predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 168 hours postdose); Day 29 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 240, 336, 672, 1344, 1848, 2016 hours postdose)
PK: AUCτ of LY3844583 - Part B (MAD - Cohort 2)
PK: AUCτ of LY3844583 (τ = 168 hrs) in Part B (MAD - Cohort 2). For Day 29, no PK samples were collected at 168 hours post dose, so data up to 144 hours post-dose were reported and used for AUC 0-τ parameter assessments.
Measured: Part B (MAD - Cohort 2): Day 1 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144, 168 hours postdose); Day 29 (Predose, end of infusion, 3, 6, 12, 24, 48, 96, 144 hours postdose)
PK: Cmax of LY3844583 - Part C: 1000 mg LY3844583 IV Q2W (Cohort 1)
PK: Cmax of LY3844583 in Part C: 1000 mg LY3844583 IV Q2W (Cohort 1)
Measured: Part C: 1000 mg LY3844583 IV Q2W (Cohort 1) : Day 1 (Predose, end of infusion, 3, 6, 72, 168, 336 hours postdose); Day 85: (Predose, end of infusion, 3, 6 and 72 hours postdose)
PK: AUCτ of LY3844583 - Part C: 1000 mg LY3844583 IV Q2W (Cohort 1)
PK: AUCτ of LY3844583 (τ = 336 hours) in Part C: 1000 mg LY3844583 IV Q2W (Cohort 1).For Day 85: No PK samples were collected beyond 72 hours post-dose, so data up to 72 hours post-dose were reported and used for AUC 0-τ parameter assessments.
Measured: Part C: 1000 mg LY3844583 IV Q2W (Cohort 1) : Day 1 (Predose, end of infusion, 3, 6, 72, 168, 336 hours postdose); Day 85: (Predose, end of infusion, 3, 6 and 72 hours postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start11 Aug 2022
- Primary completion20 Jan 2024
- Study completion20 Jan 2024
Why it stopped: Study terminated due to lack of efficacy signal in atopic dermatitis participants.
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
- 86 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
- NCT05486208
- Sponsor's protocol ID
- 18365
- Other IDs
- J3V-MC-KKAA
- Status last verified
- Jul 2026
- First submitted
- 2 Aug 2022
- Last updated
- 13 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No