HealthyPhase 1NCT03343587
A Study of LY3375880 in Healthy Participants
A Phase 1 study testing LY3375880 IV and LY3375880 SC in people with Healthy, run by Eli Lilly and Company at 1 site in United States.
Trial summary
The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm. This is a two-part study. 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?
- LY3375880 IV and LY3375880 SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 16 Nov 2018
- 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 males or females, as determined by medical history and physical examination
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Who cannot join
- Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- Are women who are of childbearing potential or who are lactating
Trial locations and contacts
1 site in 1 country.
United States1 site
Parexel Early Phase Unit at Glendale
Glendale, California, 91206
About this study
Official title: A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3375880 in Healthy Subjects
The purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.
This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.
- Conditions
- Healthy
- Being tested
- LY3375880 IV, LY3375880 SC, Placebo IV, Placebo SC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3375880 IVDrug
administered IV
LY3375880 SCDrug
administered SC
Placebo IVDrug
administered IV
Placebo SCDrug
administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3375880 Single Dose | Experimental | Single dose of LY3375880 administered IV or SC Receives: Drug: LY3375880 IV; Drug: LY3375880 SC |
| Placebo Single Dose | Placebo comparator | Single dose of placebo administered IV or SC Receives: Drug: Placebo IV; Drug: Placebo SC |
| LY3375880 Multiple Dose | Experimental | Multiple doses of LY3375880 administered IV or SC Receives: Drug: LY3375880 IV; Drug: LY3375880 SC |
| Placebo Multiple Dose | Placebo comparator | Multiple doses of placebo administered IV or SC Receives: Drug: Placebo IV; Drug: Placebo SC |
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: Pre-dose to 3 months after administration of study drug
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880
PK: Cmax of LY3375880
Measured: Pre-dose to 3 months after administration of study drug
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880
PK: AUC of LY3375880
Measured: Pre-dose to 3 months after administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start17 Nov 2017
- Primary completion16 Nov 2018
- Study completion16 Nov 2018
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
- 80 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
- NCT03343587
- Sponsor's protocol ID
- 16833
- Other IDs
- I9N-MC-FCAA
- Status last verified
- 1 Dec 2018
- First submitted
- 13 Nov 2017
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. 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 LY3375880 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03343587
- Acronym / sponsor ID
- 16833
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 16 Nov 2018 (actual)
- Study completion
- 16 Nov 2018 (actual)
- First posted
- 17 Nov 2017 (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 purpose of this study is to evaluate how well LY3375880 (study drug) is tolerated in healthy participants and what side effects may occur. The study drug will be administered either subcutaneously (SC) under the skin or intravenously (IV) into a vein in the arm.
This is a two-part study. Participants will enroll in only one part. Part one will last about 16 weeks including screening and follow-up. This part will include 2 nights at the study site. Part two will last about 20 weeks including screening and follow-up. This part will include 2 nights at the study site for each dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3375880 Single Dose | Experimental | Drug: LY3375880 IV, Drug: LY3375880 SCSingle dose of LY3375880 administered IV or SC |
| Placebo Single Dose | Placebo comparator | Drug: Placebo IV, Drug: Placebo SCSingle dose of placebo administered IV or SC |
| LY3375880 Multiple Dose | Experimental | Drug: LY3375880 IV, Drug: LY3375880 SCMultiple doses of LY3375880 administered IV or SC |
| Placebo Multiple Dose | Placebo comparator | Drug: Placebo IV, Drug: Placebo SCMultiple doses of placebo administered IV or SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are overtly healthy males or females, as determined by medical history and physical examination
- Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Key exclusion criteria (2 listed)
- Have known allergies to LY3375880, related compounds or any components of the formulation, or history of significant atopy
- Are women who are of childbearing potential or who are lactating
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 |
|---|---|---|
| LY3375880 IVadministered IV | Drug | LY3375880 Multiple Dose, LY3375880 Single Dose |
| LY3375880 SCadministered SC | Drug | LY3375880 Multiple Dose, LY3375880 Single Dose |
| Placebo IVadministered IV | Drug | Placebo Multiple Dose, Placebo Single Dose |
| Placebo SCadministered SC | Drug | Placebo Multiple Dose, Placebo Single Dose |
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: Pre-dose to 3 months after administration of study drug
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 LY3375880
Time frame: Pre-dose to 3 months after administration of study drug
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880
Time frame: Pre-dose to 3 months after administration of study drug
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 10 Dec 2018.
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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 LY3375880 IV and LY3375880 SC 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 3 inclusion and 2 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 10 Dec 2018. 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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Pre-dose to 3 months after administration of study drug). 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 10 Dec 2018.