HealthyPhase 1NCT07046559
A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants
A Phase 1 study testing LY4066708 in people with Healthy and Cancer, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The main purpose of this study is to explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- What is being tested?
- LY4066708
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 May 2025to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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, and cardiac monitoring.
- Japanese Participants Only: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- Chinese Participants Only: To qualify as Chinese for the purpose of this study, all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China, Hong Kong, Macau, or Taiwan.
- Have a body mass index (BMI) at the time of screening within the range 18.5 to 30 kilogram per meter squared (kg/m²) (inclusive).
- Participants assigned female at birth (AFAB) not of childbearing potential and participants assigned male at birth (AMAB) willing to practice effective contraception throughout the study may participate.
- Willingness to undergo study procedures which may include repeated lumbar punctures
Who cannot join
- Are individuals of childbearing potential (IOCBP). Notwithstanding their IOCBP status, participants AFAB are excluded if they are breastfeeding.
- A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- Have known allergies to LY4066708 or any components of the formulation, or history of allergic reactions to any transferrin receptor (TfR) antibodies.
- Have participated, within the 3 months of screening, in a clinical trial involving a study intervention (other than the study intervention used in this study). If the previous investigational product has a long half-life (t½), 3 months or 5 half-lives (whichever is longer) should have passed.
- Are persons who have previously completed or withdrawn from this study and have previously received the study intervention. This exclusion criterion does not apply to subjects who are allowed to rescreen prior to randomization.
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- Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, or may confound ECG data analysis.
- Show evidence of hepatitis C and/or positive hepatitis C antibody.
- Current infection with hepatitis B virus (HBV) or evidence of past infection with HBV, that is, positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core total antibody (anti-HBc).
- A marked baseline prolongation of time from the start of the Q wave to the end of the T wave/ corrected QT interval (QT/QTc) interval (for example, repeated demonstration of a corrected time from the start of the Q wave to the end of the T wave interval - Fridericia formula (QTcF) interval greater than 450 ms).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
United Kingdom1 site, 1 recruiting
- Recruiting
Fortrea Clinical Research Unit
Holbeck, Leeds, LS11 9EH
1-866-429-3700
Firas Almazedi
About this study
The main purpose of this study is to explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant.
- Being tested
- LY4066708, Placebo
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4066708Drug
Administered IV
PlaceboDrug
Administered IV
LY4066708Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Part A Cohort 1: Single-Ascending Dose (SAD)- LY4066708 | Experimental | LY4066708 administered by intravenous (IV) injection Receives: Drug: LY4066708 |
| Part A Cohort 2: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part A Cohort 3A: SAD- LY4066708 | Experimental | LY4066708 administered by subcutaneous (SC) injection Receives: Drug: LY4066708 |
| Part A Cohort 3B: SAD- LY4066708 | Experimental | LY4066708 administered by SC injection Receives: Drug: LY4066708 |
| Part A Cohort 4: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part A Cohort 5: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part A Cohort 5A: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part A Cohort 6A: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part A Cohort 6: SAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part B Cohort 1: Multiple-Ascending Dose (MAD)- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part B Cohort 2: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part B Cohort 3: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Part B Cohort 4: MAD- LY4066708 | Experimental | LY4066708 administered by IV injection Receives: Drug: LY4066708 |
| Placebo | Placebo comparator | Placebo administered by IV injection Receives: Drug: Placebo |
| Placebo- Part A Cohort 3A and Part A Cohort 3B. | Placebo comparator | Placebo administered by SC injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants with One or More Serious Adverse Events (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 Adverse Events module
Measured: Baseline up to Week 12
Part B: Number of Participants with One or More Serious Adverse Events (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 Adverse Events module
Measured: Screening to Day 22
Secondary outcomes (4)
Part A: Pharmacokinetics (PK)- Area Under the Plasma Concentration Versus Time Curve (AUC0-168)
To evaluate PK after a single dose of LY4066708
Measured: Predose up to day 15
Part B: Pharmacokinetics (PK)- AUC0-168
To evaluate PK after multiple doses of LY4066708
Measured: Day 1 up to day 7
Part A: Pharmacokinetics (PK)- Maximum Observed Drug Concentration (Cmax)
To evaluate PK after a single dose of LY4066708
Measured: Predose up to day 15
Part B: Pharmacokinetics (PK)- Cmax
To evaluate PK after a single dose of LY4066708
Measured: After dose 3, up to day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start13 May 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
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
- 104 participants (estimated)
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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046559
- Sponsor's protocol ID
- 27332
- Other IDs
- J5Z-MC-OTAA
- Status last verified
- Feb 2026
- First submitted
- 13 May 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07046559
- Acronym / sponsor ID
- 27332
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 1 Jul 2025 (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 explore the safety and any side effects of LY4066708 in healthy participants. The study will also measure how much LY4066708 gets into the bloodstream and the central nervous system and how long it takes the body to remove it. The study will last up to 24 weeks for each participant.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 15
| Arm | Type | Receives |
|---|---|---|
| Part A Cohort 1: Single-Ascending Dose (SAD)- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by intravenous (IV) injection |
| Part A Cohort 2: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part A Cohort 3A: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by subcutaneous (SC) injection |
| Part A Cohort 3B: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by SC injection |
| Part A Cohort 4: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part A Cohort 5: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part A Cohort 5A: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part A Cohort 6A: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part A Cohort 6: SAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part B Cohort 1: Multiple-Ascending Dose (MAD)- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part B Cohort 2: MAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part B Cohort 3: MAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Part B Cohort 4: MAD- LY4066708 | Experimental | Drug: LY4066708LY4066708 administered by IV injection |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered by IV injection |
| Placebo- Part A Cohort 3A and Part A Cohort 3B. | Placebo comparator | Drug: PlaceboPlacebo administered by SC injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Japanese Participants Only: To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
- Chinese Participants Only: To qualify as Chinese for the purpose of this study, all 4 of the participants' biological grandparents must be of exclusive Chinese descent and born in China, Hong Kong, Macau, or Taiwan.
- Have a body mass index (BMI) at the time of screening within the range 18.5 to 30 kilogram per meter squared (kg/m²) (inclusive).
- Participants assigned female at birth (AFAB) not of childbearing potential and participants assigned male at birth (AMAB) willing to practice effective contraception throughout the study may participate.
Key exclusion criteria (10 listed)
- Are individuals of childbearing potential (IOCBP). Notwithstanding their IOCBP status, participants AFAB are excluded if they are breastfeeding.
- A history of additional risk factors for Torsades de Pointes (for example, heart failure, hypokalemia, family history of Long QT Syndrome).
- The use of concomitant medications that prolong the QT/QTc interval.
- Have known allergies to LY4066708 or any components of the formulation, or history of allergic reactions to any transferrin receptor (TfR) antibodies.
- Have participated, within the 3 months of screening, in a clinical trial involving a study intervention (other than the study intervention used in this study). If the previous investigational product has a long half-life (t½), 3 months or 5 half-lives (whichever is longer) should have passed.
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 |
|---|---|---|
| LY4066708Administered IV | Drug | Part A Cohort 1: Single-Ascending Dose (SAD)- LY4066708, Part A Cohort 2: SAD- LY4066708, Part A Cohort 4: SAD- LY4066708, Part A Cohort 5: SAD- LY4066708, Part A Cohort 5A: SAD- LY4066708, Part A Cohort 6: SAD- LY4066708, Part A Cohort 6A: SAD- LY4066708, Part B Cohort 1: Multiple-Ascending Dose (MAD)- LY4066708, Part B Cohort 2: MAD- LY4066708, Part B Cohort 3: MAD- LY4066708, Part B Cohort 4: MAD- LY4066708 |
| PlaceboAdministered IV | Drug | Placebo |
| LY4066708Administered SC | Drug | Part A Cohort 3A: SAD- LY4066708, Part A Cohort 3B: SAD- LY4066708 |
| PlaceboAdministered SC | Drug | Placebo- Part A Cohort 3A and Part A Cohort 3B. |
Primary outcome
Part A: Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline up to Week 12
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
Part B: Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Screening to Day 22
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
4 secondary outcomes
Part A: Pharmacokinetics (PK)- Area Under the Plasma Concentration Versus Time Curve (AUC0-168)
Time frame: Predose up to day 15
Part B: Pharmacokinetics (PK)- AUC0-168
Time frame: Day 1 up to day 7
Part A: Pharmacokinetics (PK)- Maximum Observed Drug Concentration (Cmax)
Time frame: Predose up to day 15
Part B: Pharmacokinetics (PK)- Cmax
Time frame: After dose 3, up to day 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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 LY4066708 in people with Healthy and Cancer, run by Eli Lilly and Company at 1 site in United Kingdom.
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 6 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 3 Mar 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline up to Week 12). The study lists 2 primary outcomes in all. 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 3 Mar 2026.