HealthyPhase 1FPABNCT06690996

A Study of LY4005130 in Healthy Participants

A Phase 1 study testing LY4005130 in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate how well LY4005130 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY4005130
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 110 participants
Where: 1 siteUnited States
Study dates: 8 Nov 2024to 28 Apr 2026
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 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram) ECG. If any values are outside the normal range and considered to be significant, for example, elevated white blood cell count, the respective test may be repeated once at the discretion of the investigator without consultation with the sponsor
If enrolled as Japanese or Chinese, the entry requirements are as follows:
To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and born in Japan
To qualify as Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
Have a body weight 45 kilogram (kg) or greater and body mass index greater than 18 and less than 32 kilogram per square meter (kg/m²)

Who cannot join

Are an individual of childbearing potential (IOCBP)
Have known allergies to LY4005130, related compounds, or any components of the formulation
Have received a live vaccine within 28 days of screening or intend to do so during the study or within 28 days after the study
Non-live or inactivated vaccinations are allowed
Bacillus Calmette Guerin vaccine must not have been administered within 12 months before screening
Had a surgical procedure within 12 weeks before screening;

Show all 16Show fewer

during the study, or
within 28 days after the study
Have a history of allergy to medications that could be used to treat infusion reactions, or to the drug excipients
Have a history or presence of multiple or severe allergies, anaphylactic reaction to prescription or nonprescription drugs, significant history of atopy, or a history of severe posttreatment hypersensitivity reactions. These reactions include, but are not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis
Have a diagnosis or history of malignant disease within 5 years prior to screening, with the following exceptions
Basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, or
Cervical carcinoma in situ, with no evidence of recurrence within the 5 years prior to screening
Have had breast cancer within the past 10 years
Have a history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the participant to infection that, in the opinion of the sponsor or investigator, poses an unacceptable risk to the participant
Have a current or recent acute, active infection

Trial locations and contacts

1 site in 1 country.

United States1 site

Fortrea Clinical Research Unit
Dallas, Texas, 75247

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Placebo-controlled, Investigator and Participant Blinded, Single-ascending Dose and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4005130 in Healthy Participants.

Part A for the single-ascending doses (SAD) of the study will last about 12 weeks with 9 visits. Part B for the multiple-ascending doses (MAD) of the study will either last about 16 weeks with 13 visits or 26 weeks with 14 visits not including screening.

Conditions: Healthy
Being tested: LY4005130, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LY4005130Drug
Administered IV
LY4005130Drug
Administered SC
PlaceboDrug
Administered IV
PlaceboDrug
Administered SC

Study groups in NCT06690996
Study group	Role	What they receive
LY4005130 Part A (SAD) SC	Experimental	A single-ascending dose of LY4005130 administered subcutaneously (SC) Receives: Drug: LY4005130
Placebo Part A (SAD) SC	Placebo comparator	Placebo administered SC Receives: Drug: Placebo
LY4005130 Part A (SAD) IV	Experimental	A single-ascending dose of LY4005130 administered intravenously (IV) Receives: Drug: LY4005130
Placebo Part A (SAD) IV	Placebo comparator	Placebo administered IV Receives: Drug: Placebo
LY4005130 Part A (SAD) Optional	Experimental	A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts Receives: Drug: LY4005130
Placebo Part A (SAD) Optional	Placebo comparator	A single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts Receives: Drug: Placebo
LY4005130 Part B (MAD) IV	Experimental	Multiple-ascending doses of LY4005130 administered IV Receives: Drug: LY4005130
Placebo Part B (MAD) IV	Placebo comparator	Placebo administered IV Receives: Drug: Placebo
LY4005130 Part B (MAD) SC or IV	Experimental	Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts Receives: Drug: LY4005130
Placebo Part B (MAD) SC or IV	Placebo comparator	Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts Receives: Drug: Placebo
LY4005130 Part B (MAD) Optional	Experimental	Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts Receives: Drug: LY4005130
Placebo Part B (MAD) Optional	Placebo comparator	Multiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts 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 and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to Study Completion (Up to 26 Weeks)

Secondary outcomes (2)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4005130
Cmax of LY4005130
Measured: Baseline to Study Completion (Up to 26 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4005130
AUC of LY4005130
Measured: Baseline to Study Completion (Up to 26 Weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Nov 202428 Apr 2026

First posted15 Nov 2024
Study start8 Nov 2024
Primary completion28 Apr 2026
Study completion28 Apr 2026

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: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06690996
Sponsor's protocol ID: 27231
Other IDs: J5D-MC-FPAB
Acronym: FPAB
Status last verified: Jun 2026
First submitted: 14 Nov 2024
Last updated: 23 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized, Placebo-controlled, Investigator and Participant Blinded, Single-ascending Dose and Multiple-ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4005130 in Healthy Participants.
ClinicalTrials.gov ID: NCT06690996
Acronym / sponsor ID: FPAB / 27231
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 8 Nov 2024 (actual)
Primary completion: 28 Apr 2026 (actual)
Study completion: 28 Apr 2026 (actual)
First posted: 15 Nov 2024 (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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 12

Arm	Type	Receives
LY4005130 Part A (SAD) SC	Experimental	Drug: LY4005130A single-ascending dose of LY4005130 administered subcutaneously (SC)
Placebo Part A (SAD) SC	Placebo comparator	Drug: PlaceboPlacebo administered SC
LY4005130 Part A (SAD) IV	Experimental	Drug: LY4005130A single-ascending dose of LY4005130 administered intravenously (IV)
Placebo Part A (SAD) IV	Placebo comparator	Drug: PlaceboPlacebo administered IV
LY4005130 Part A (SAD) Optional	Experimental	Drug: LY4005130A single-ascending dose of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part A (SAD) Optional	Placebo comparator	Drug: PlaceboA single-ascending dose of placebo administered either SC or IV depending on emerging data from earlier cohorts
LY4005130 Part B (MAD) IV	Experimental	Drug: LY4005130Multiple-ascending doses of LY4005130 administered IV
Placebo Part B (MAD) IV	Placebo comparator	Drug: PlaceboPlacebo administered IV
LY4005130 Part B (MAD) SC or IV	Experimental	Drug: LY4005130Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part B (MAD) SC or IV	Placebo comparator	Drug: PlaceboMultiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts
LY4005130 Part B (MAD) Optional	Experimental	Drug: LY4005130Multiple-ascending doses of LY4005130 administered either SC or IV depending on emerging data from earlier cohorts
Placebo Part B (MAD) Optional	Placebo comparator	Drug: PlaceboMultiple-ascending doses of placebo administered either SC or IV depending on emerging data from earlier cohorts

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead (electrocardiogram) ECG. If any values are outside the normal range and considered to be significant, for example, elevated white blood cell count, the respective test may be repeated once at the discretion of the investigator without consultation with the sponsor
If enrolled as Japanese or Chinese, the entry requirements are as follows:
Have a body weight 45 kilogram (kg) or greater and body mass index greater than 18 and less than 32 kilogram per square meter (kg/m²)

Key exclusion criteria (16 listed)

Are an individual of childbearing potential (IOCBP)
Have known allergies to LY4005130, related compounds, or any components of the formulation
Have received a live vaccine within 28 days of screening or intend to do so during the study or within 28 days after the study
Had a surgical procedure within 12 weeks before screening;
Have a history of allergy to medications that could be used to treat infusion reactions, or to the drug excipients

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
LY4005130Administered IV	Drug	LY4005130 Part A (SAD) IV, LY4005130 Part A (SAD) Optional, LY4005130 Part B (MAD) IV, LY4005130 Part B (MAD) Optional, LY4005130 Part B (MAD) SC or IV
LY4005130Administered SC	Drug	LY4005130 Part A (SAD) Optional, LY4005130 Part A (SAD) SC, LY4005130 Part B (MAD) Optional, LY4005130 Part B (MAD) SC or IV
PlaceboAdministered IV	Drug	Placebo Part A (SAD) IV, Placebo Part A (SAD) Optional, Placebo Part B (MAD) IV, Placebo Part B (MAD) Optional, Placebo Part B (MAD) SC or IV
PlaceboAdministered SC	Drug	Placebo Part A (SAD) Optional, Placebo Part A (SAD) SC, Placebo Part B (MAD) Optional, Placebo Part B (MAD) SC or IV

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 to Study Completion (Up to 26 Weeks)
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

2 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4005130
Time frame: Baseline to Study Completion (Up to 26 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4005130
Time frame: Baseline to Study Completion (Up to 26 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 23 Jun 2026.
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 8 AM - 8 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 LY4005130 in people with Healthy, run by Eli Lilly and Company at 1 site 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 5 inclusion and 16 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 23 Jun 2026. 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 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?

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 to Study Completion (Up to 26 Weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06690996.

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 23 Jun 2026.