HealthyPhase 1NCT03053622
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
A Phase 1 study testing Mirikizumab Test and Mirikizumab Reference in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. 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?
- Mirikizumab Test and Mirikizumab Reference
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2017to 3 Apr 2018
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
- Have medical test results that are acceptable for the study
- Must be willing to make oneself available for the whole study and be willing to follow study procedures
Who cannot join
- Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have known allergies to compounds or drugs similar to Mirikizumab
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
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, West Yorkshire, LS2 9LH
About this study
Official title: A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
- Conditions
- Healthy
- Being tested
- Mirikizumab Test, Mirikizumab Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirikizumab TestBiological
Also called LY3074828
Administered SC
Mirikizumab TestBiological
Also called LY3074828
Administered IV
Mirikizumab ReferenceBiological
Also called LY3074828
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab Test Subcutaneous (SC) 1 | Experimental | 250 mg mirikizumab test formulation given as a single injection SC in healthy participants Receives: Biological: Mirikizumab Test |
| Mirikizumab Test SC 2 | Experimental | 250 mg mirikizumab test formulation given as two injections given SC in healthy participants Receives: Biological: Mirikizumab Test |
| Mirikizumab Test Intravenous (IV) | Experimental | 250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants Receives: Biological: Mirikizumab Test |
| Mirikizumab Reference | Active comparator | 250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants Receives: Biological: Mirikizumab Reference |
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 From 0 to Infinity (AUC[0-∞]) of Mirikizumab
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-∞]) of Mirikizumab
Measured: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Secondary outcomes (2)
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
Measured: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
Measured: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start24 Apr 2017
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- None (open label)
- Enrolment
- 67 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
- NCT03053622
- Sponsor's protocol ID
- 16542
- Other IDs
- I6T-MC-AMAL, 2016-003584-18, 2016
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2017
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Dose Study to Assess the Relative Bioavailability, Absolute Bioavailability, and Tolerability of LY3074828 Formulations in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03053622
- Acronym / sponsor ID
- 16542
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 15 Feb 2017 (actual)
- Results
- Posted 21 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted to compare how much mirikizumab, in two different formulations, is absorbed into the bloodstream and how long the body takes to get rid of it, when given as an injection under the skin or into the veins. Side effects of the injection will be collected. Each participant will be in the study for about 18 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab Test Subcutaneous (SC) 1 | Experimental | Biological: Mirikizumab Test250 mg mirikizumab test formulation given as a single injection SC in healthy participants |
| Mirikizumab Test SC 2 | Experimental | Biological: Mirikizumab Test250 mg mirikizumab test formulation given as two injections given SC in healthy participants |
| Mirikizumab Test Intravenous (IV) | Experimental | Biological: Mirikizumab Test250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants |
| Mirikizumab Reference | Active comparator | Biological: Mirikizumab Reference250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have a screening body mass index (BMI) of greater than 18 and less than or equal to 32 kilograms per meter squared (kg/m²), inclusive
- Have medical test results that are acceptable for the study
- Must be willing to make oneself available for the whole study and be willing to follow study procedures
Key exclusion criteria (4 listed)
- Are currently participating or recently participated in a clinical trial or any other type of medical research judged to be incompatible with this study
- Have known allergies to compounds or drugs similar to Mirikizumab
- Have previously participated or withdrawn from this study
- Have or used to have health problems or medical test results that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
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 |
|---|---|---|
| Mirikizumab TestAlso: LY3074828Administered SC | Biological | Mirikizumab Test SC 2, Mirikizumab Test Subcutaneous (SC) 1 |
| Mirikizumab TestAlso: LY3074828Administered IV | Biological | Mirikizumab Test Intravenous (IV) |
| Mirikizumab ReferenceAlso: LY3074828Administered SC | Biological | Mirikizumab Reference |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC[0-∞]) of Mirikizumab
2 secondary outcomes
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
Time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 Mirikizumab Test and Mirikizumab Reference 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 3 inclusion and 4 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 21 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 From 0 to Infinity (AUC[0-∞]) of Mirikizumab (time frame: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose). 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 21 Feb 2024.