HealthyPhase 1NCT06007638
A Single and Multiple Ascending Dose Study of LY3876602 in Healthy Participants
A Phase 1 study testing LY3876602 in people with Healthy, run by Eli Lilly and Company at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3876602
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Aug 2023to 20 Sep 2025
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants who are overtly healthy as determined by medical evaluation
- Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
- Male or female participants of nonchildbearing potential
Who cannot join
- Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
- Have allergies to diphenhydramine, epinephrine, or methylprednisolone
- Have serious or unstable medical conditions,
- History of skin wounding within 14 days of screening or current skin infection
- Are unwilling to stop alcohol consumption 48 hours prior to each dosing
- Have active or latent tuberculosis
- Participants in the cohorts undergoing lumbar puncture have an allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants
The aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.
Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.
- Conditions
- Healthy
- Being tested
- LY3876602, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3876602Drug
Administered IV.
PlaceboDrug
Administered IV.
| Study group | Role | What they receive |
|---|---|---|
| LY3876602 | Experimental | Single ascending doses of LY3876602 administered intravenously (IV). Receives: Drug: LY3876602 |
| Placebo | Placebo comparator | Placebo administered IV. Receives: Drug: Placebo |
| LY3876602 Part B (MAD) | Experimental | Multiple ascending doses of LY3876602 will be administered intravenously (IV). Receives: Drug: LY3876602 |
| Placebo: Part B (MAD) | Placebo comparator | Placebo administered IV 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 Serious Adverse Event(s) (SAEs) 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, will be reported in the Reported Adverse Events module
Measured: Baseline up to 28 weeks
Secondary outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602
PK: AUC of LY3876602
Measured: Predose up to 28 weeks
PK: Maximum Observed Drug Concentration (Cmax) of LY3876602
PK: Cmax of LY3876602
Measured: Predose up to 28 weeks
PK: Half-life (t1/2) of LY3876602
PK: t1/2 of LY3876602
Measured: Predose up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start23 Aug 2023
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
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
- 74 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
- NCT06007638
- Sponsor's protocol ID
- 18734
- Other IDs
- J4K-MC-LALA, 2023-504838-21-00, 2023
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2023
- Last updated
- 24 Sep 2025
- 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 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3876602 in Healthy Participants
- ClinicalTrials.gov ID
- NCT06007638
- Acronym / sponsor ID
- 18734
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 20 Sep 2025 (actual)
- Study completion
- 20 Sep 2025 (actual)
- First posted
- 23 Aug 2023 (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 aim of this study is to evaluate the safety, tolerability and PK of LY3876602 after administering it as single ascending doses and, following a data review, proceeding to multiple ascending doses in healthy participants. Blood tests will also be performed to check how much LY3876602 gets into the bloodstream and cerebrospinal fluid (CSF) and how long it takes the body to eliminate it.
Following the screening visit for Part A, the study will last up to approximately 20 weeks., and a subgroup of participants will consent to CSF collections The study will last up to approximately 28 weeks for Part B. All participants will consent to CSF collections.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3876602 | Experimental | Drug: LY3876602Single ascending doses of LY3876602 administered intravenously (IV). |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered IV. |
| LY3876602 Part B (MAD) | Experimental | Drug: LY3876602Multiple ascending doses of LY3876602 will be administered intravenously (IV). |
| Placebo: Part B (MAD) | Placebo comparator | Drug: PlaceboPlacebo administered IV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female participants who are overtly healthy as determined by medical evaluation
- Have a body mass index with the range of 18 and less than or equal to (≤) 32 kilograms per square meter (kg/m²)
- Male or female participants of nonchildbearing potential
Key exclusion criteria (7 listed)
- Have a family history, defined as a parent or first-degree relative, of genetic neurodegenerative disorders
- Have allergies to diphenhydramine, epinephrine, or methylprednisolone
- Have serious or unstable medical conditions,
- History of skin wounding within 14 days of screening or current skin infection
- Are unwilling to stop alcohol consumption 48 hours prior to each 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 |
|---|---|---|
| LY3876602Administered IV. | Drug | LY3876602, LY3876602 Part B (MAD) |
| PlaceboAdministered IV. | Drug | Placebo, Placebo: Part B (MAD) |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to 28 weeks
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
3 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3876602
Time frame: Predose up to 28 weeks
PK: Maximum Observed Drug Concentration (Cmax) of LY3876602
Time frame: Predose up to 28 weeks
PK: Half-life (t1/2) of LY3876602
Time frame: Predose up to 28 weeks
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 24 Sep 2025.
- 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 LY3876602 in people with Healthy, run by Eli Lilly and Company at 1 site in Netherlands.
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 7 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 24 Sep 2025. 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 Netherlands. 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to 28 weeks). 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 24 Sep 2025.