HealthyPhase 1NCT04352114
A Study of LY3461767 in Healthy Participants
A Phase 1 study testing LY3461767 - SC and LY3461767 - IV in people with Healthy, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3461767 - SC and LY3461767 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 15 Jun 2020to 13 Jan 2021
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are healthy males, or females of non-child-bearing potential
- Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
- Have clinical laboratory tests within normal ranges as judged by investigator
- Have pulse rate and blood pressure within normal ranges as judged by investigator
Who cannot join
- Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
- Regularly use known drugs of abuse
- Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
- Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
Show all 10Show fewer
- Smoke more than 10 cigarettes per day
- Are current or former smokers with 30-pack-year smoking history
- Have a diagnosis or history of any malignancy
- Have not had appropriate cancer screening, in accordance with country specific guidance
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Covance Dallas
Dallas, Texas, 75247
Covance Clinical Research Inc
Daytona Beach, Florida, 32117
About this study
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants
The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.
- Conditions
- Healthy
- Being tested
- LY3461767 - SC, LY3461767 - IV, Placebo - SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3461767 - SCDrug
Administered SC.
LY3461767 - IVDrug
Administered IV.
Placebo - SCDrug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3461767 - Subcutaneous (SC) | Experimental | LY3461767 administered SC. Receives: Drug: LY3461767 - SC |
| Placebo - SC | Placebo comparator | Placebo administered SC. Receives: Drug: Placebo - SC |
| LY3461767 - Intravenous (IV) | Experimental | LY3461767 administered IV. Receives: Drug: LY3461767 - IV |
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 through Day 29
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3461767
PK: Cmax of LY3461767
Measured: Baseline through Day 29
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767
PK: AUC of LY3461767
Measured: Baseline through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start15 Jun 2020
- Primary completion13 Jan 2021
- Study completion13 Jan 2021
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 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
- NCT04352114
- Sponsor's protocol ID
- 17517
- Other IDs
- J2L-MC-EZBA
- Status last verified
- Feb 2021
- First submitted
- 16 Apr 2020
- Last updated
- 5 Feb 2021
- 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 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3461767 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04352114
- Acronym / sponsor ID
- 17517
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 13 Jan 2021 (actual)
- Study completion
- 13 Jan 2021 (actual)
- First posted
- 20 Apr 2020 (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 in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LY3461767 - Subcutaneous (SC) | Experimental | Drug: LY3461767 - SCLY3461767 administered SC. |
| Placebo - SC | Placebo comparator | Drug: Placebo - SCPlacebo administered SC. |
| LY3461767 - Intravenous (IV) | Experimental | Drug: LY3461767 - IVLY3461767 administered IV. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are healthy males, or females of non-child-bearing potential
- Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
- Have clinical laboratory tests within normal ranges as judged by investigator
- Have pulse rate and blood pressure within normal ranges as judged by investigator
Key exclusion criteria (10 listed)
- Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
- Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
- Regularly use known drugs of abuse
- Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
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 |
|---|---|---|
| LY3461767 - SCAdministered SC. | Drug | LY3461767 - Subcutaneous (SC) |
| LY3461767 - IVAdministered IV. | Drug | LY3461767 - Intravenous (IV) |
| Placebo - SCAdministered SC. | Drug | Placebo - SC |
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 through Day 29
A summary of 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 Observed Drug Concentration (Cmax) of LY3461767
Time frame: Baseline through Day 29
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3461767
Time frame: Baseline through Day 29
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 Feb 2021.
- 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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3461767 - SC and LY3461767 - IV in people with Healthy, run by Eli Lilly and Company at 3 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Singapore. 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 through Day 29). 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 Feb 2021.