HealthyPhase 1NCT03220126
A Study to Assess the Amount of LY3074828 That Gets Into the Body When Given With LY9999QS, in Healthy Participants
A Phase 1 study testing LY3074828 and LY900021 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given together with LY9999QS compared to LY3074828 alone. 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?
- LY3074828 and LY900021
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2017to 23 Feb 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
- Have venous access sufficient to allow for blood sampling and administration of investigational product
- Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Who cannot join
- Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
- Must not be immunocompromised
- Must not have known hypersensitivity to hyaluronidases
- Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
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- Must not have significant allergies to humanised monoclonal antibodies
- Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
- Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Must not have had breast cancer within the past 10 years
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Leeds
About this study
Official title: An Assessment of the Absolute and Relative Bioavailability of Subcutaneous Doses of LY3074828 When Coadministered With LY9999QS to Healthy Subjects
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations will also be evaluated and information about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant the total duration of the clinical trial will be approximately 13 weeks, not including screening.
- Conditions
- Healthy
- Being tested
- LY3074828, LY900021
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3074828Biological
Administered IV
LY900021Biological
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3074828 - Treatment 1 | Experimental | Single intravenous (IV) dose of LY3074828 Receives: Biological: LY3074828 |
| LY900021 - Treatment 2 | Experimental | Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS) Receives: Biological: LY900021 |
| LY900021 - Treatment 3 | Experimental | Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) Receives: Biological: LY900021 |
| LY900021 - Treatment 4 | Experimental | Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) Receives: Biological: LY900021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828
PK: AUC of LY3074828
Measured: Baseline through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start17 Jul 2017
- Primary completion23 Feb 2018
- Study completion23 Feb 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
- Model description
- Treatments 2 and 3 of LY900021 will be administered in parallel with LY3074828. Treatments 2, 3, and 4 of LY900021 will be administered sequentially pending a safety review after administration of Treatments 2 and 3.
- Masking
- None (open label)
- Enrolment
- 72 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
- NCT03220126
- Sponsor's protocol ID
- 16861
- Other IDs
- I9O-MC-AABA, 2017-001242-10, 2017
- Status last verified
- Mar 2018
- First submitted
- 14 Jul 2017
- Last updated
- 29 Mar 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 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Assessment of the Absolute and Relative Bioavailability of Subcutaneous Doses of LY3074828 When Coadministered With LY9999QS to Healthy Subjects
- ClinicalTrials.gov ID
- NCT03220126
- Acronym / sponsor ID
- 16861
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 23 Feb 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 18 Jul 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 look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations will also be evaluated and information about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant the total duration of the clinical trial will be approximately 13 weeks, not including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Treatments 2 and 3 of LY900021 will be administered in parallel with LY3074828. Treatments 2, 3, and 4 of LY900021 will be administered sequentially pending a safety review after administration of Treatments 2 and 3.
| Arm | Type | Receives |
|---|---|---|
| LY3074828 - Treatment 1 | Experimental | Biological: LY3074828Single intravenous (IV) dose of LY3074828 |
| LY900021 - Treatment 2 | Experimental | Biological: LY900021Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS) |
| LY900021 - Treatment 3 | Experimental | Biological: LY900021Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) |
| LY900021 - Treatment 4 | Experimental | Biological: LY900021Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Have venous access sufficient to allow for blood sampling and administration of investigational product
- Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
Key exclusion criteria (10 listed)
- Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
- Must not show evidence of active or latent tuberculosis (TB)
- Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
- Must not be immunocompromised
- Must not have known hypersensitivity to hyaluronidases
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 |
|---|---|---|
| LY3074828Administered IV | Biological | LY3074828 - Treatment 1 |
| LY900021Administered SC | Biological | LY900021 - Treatment 2, LY900021 - Treatment 3, LY900021 - Treatment 4 |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828
Time frame: Baseline through Day 85
PK: AUC of LY3074828
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 29 Mar 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 LY3074828 and LY900021 in people with Healthy, 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 2 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 29 Mar 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 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. 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?
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828 (time frame: Baseline through Day 85). 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 29 Mar 2018.