HealthyPhase 1NCT05042310
A Study of LY3541860 in Healthy Japanese and Non-Japanese Participants
A Phase 1 study testing LY3541860 in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.
Trial summary
The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3541860
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteJapan
- Study dates
- 11 Nov 2021to 27 Dec 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are male or female not of childbearing potential
- Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg)
- Have veins suitable for blood sampling
Who cannot join
- Have or used to have health problems or laboratory test results or 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 TB
- Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years
- Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Have previously completed a clinical trial investigating any other molecule targeting CD19, CD20 or have previously discontinued from this study after receiving LY3541860
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants
The main purpose of this study is to evaluate the safety and tolerability of LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.
- Conditions
- Healthy
- Being tested
- LY3541860, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3541860Drug
Administered either IV or SC.
PlaceboDrug
Administered either IV or SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3541860 (Part A) | Experimental | Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC). Receives: Drug: LY3541860 |
| LY3541860 (Part B) | Experimental | Multiple doses of LY3541860 administered either IV or SC. Receives: Drug: LY3541860 |
| Placebo (Part A) | Placebo comparator | Single doses of Placebo administered either IV or SC. Receives: Drug: Placebo |
| Placebo (Part B) | Placebo comparator | Multiple doses of Placebo administered either IV or SC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline through Day 113
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860
PK: Cmax of LY3541860
Measured: Predose on Day 1 through Day 113
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860
PK: AUC of LY3541860
Measured: Predose on Day 1 through Day 113
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start11 Nov 2021
- Primary completion27 Dec 2023
- Study completion27 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 94 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
- NCT05042310
- Sponsor's protocol ID
- 18115
- Other IDs
- J3K-MC-KIAA
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2021
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Participant- and Investigator-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3541860 in Healthy Japanese and Non-Japanese Participants
- ClinicalTrials.gov ID
- NCT05042310
- Acronym / sponsor ID
- 18115
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 27 Dec 2023 (actual)
- Study completion
- 27 Dec 2023 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
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 LY3541860 in healthy Japanese and non-Japanese participants. The study will also assess how fast LY3541860 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants. The study will last up to approximately 113 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3541860 (Part A) | Experimental | Drug: LY3541860Single doses of LY3541860 administered intravenously (IV) or subcutaneously (SC). |
| LY3541860 (Part B) | Experimental | Drug: LY3541860Multiple doses of LY3541860 administered either IV or SC. |
| Placebo (Part A) | Placebo comparator | Drug: PlaceboSingle doses of Placebo administered either IV or SC. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboMultiple doses of Placebo administered either IV or SC. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are male or female not of childbearing potential
- Have a body weight between 18 and 32 kilograms per square meter (kg/m²) and a body weight ≥ 50 kilograms (kg)
- Have veins suitable for blood sampling
Key exclusion criteria (8 listed)
- Have or used to have health problems or laboratory test results or 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 TB
- Have had breast cancer within the past 10 years or had lymphoma, leukemia, or any malignancy within the past 5 years
- Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive
- Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
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 |
|---|---|---|
| LY3541860Administered either IV or SC. | Drug | LY3541860 (Part A), LY3541860 (Part B) |
| PlaceboAdministered either IV or SC. | Drug | Placebo (Part A), Placebo (Part B) |
Primary outcome
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Day 113
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3541860
Time frame: Predose on Day 1 through Day 113
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3541860
Time frame: Predose on Day 1 through Day 113
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3541860 in people with Healthy, run by Eli Lilly and Company at 1 site in Japan.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Day 113). 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 5 Apr 2024.