HealthyPhase 1NCT02568423

A Study of Mirikizumab (LY3074828) in Healthy Participants

A Phase 1 study testing Mirikizumab - IV and Mirikizumab - SC in people with Healthy, run by Eli Lilly and Company at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The main purpose of this study is to explore the safety and tolerability of mirikizumab in healthy Japanese and Caucasian participants. The study will also estimate how much mirikizumab gets into the blood stream and how long it takes the body to remove it. Read more about this study

Who is it for?: Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Mirikizumab - IV and Mirikizumab - SC
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 2 Dec 2015to 24 Oct 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 20 to 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy males or females, as determined by medical history and physical examination.
Are first generation Japanese or are Caucasian.
Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Who cannot join

Have had symptomatic herpes zoster within 3 months of screening.
Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
Have received live vaccine(s) within 1 month of screening or intend to during the study.
Are immunocompromised.
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

Trial locations and contacts

1 site in 1 country.

United States1 site

WCCT Global
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects

Conditions: Healthy
Being tested: Mirikizumab - IV, Mirikizumab - SC, Placebo - IV, Placebo - SC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mirikizumab - IVDrug
Also called LY3074828
Administered IV
Mirikizumab - SCDrug
Also called LY3074828
Administered SC
Placebo - IVDrug
Administered IV
Placebo - SCDrug
Administered SC

Study groups in NCT02568423
Study group	Role	What they receive
Mirikizumab IV	Experimental	Participants received 200mg Mirikizumab by intravenously. Receives: Drug: Mirikizumab - IV
Mirikizumab SC	Experimental	Participants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously. Receives: Drug: Mirikizumab - SC
Placebo IV	Placebo comparator	Participants received placebo by intravenously. Receives: Drug: Placebo - IV
Placebo SC	Placebo comparator	Participants received placebo by subcutaneously. Receives: 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
SAE is any adverse event (AE) from this study that results in one of the following outcomes:
1. death
2. initial or prolonged inpatient hospitalization
3. a life-threatening experience (that is, immediate risk of dying)
4. persistent or significant disability/incapacity
5. congenital anomaly/birth defect
6. considered significant by the investigator for any other reason
Measured: Baseline through Day 85

Secondary outcomes (2)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab.
Measured: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab
Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab.
Measured: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 201524 Oct 2018

First posted5 Oct 2015 (estimated)
Study start2 Dec 2015
Primary completion16 Jul 2018
Study completion24 Oct 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02568423
Sponsor's protocol ID: 16172
Other IDs: I6T-JE-AMAD
Status last verified: Feb 2024
First submitted: 2 Oct 2015
Last updated: 8 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Japanese and Caucasian Healthy Subjects
ClinicalTrials.gov ID: NCT02568423
Acronym / sponsor ID: 16172
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 2 Dec 2015 (actual)
Primary completion: 16 Jul 2018 (actual)
Study completion: 24 Oct 2018 (actual)
First posted: 5 Oct 2015 (estimated)
Results: Posted 8 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Mirikizumab IV	Experimental	Drug: Mirikizumab - IVParticipants received 200mg Mirikizumab by intravenously.
Mirikizumab SC	Experimental	Drug: Mirikizumab - SCParticipants received single dose of either 60mgor 200mg 0r 600mg or 1200mg or 2400mg Mirikizumab by subcutaneously.
Placebo IV	Placebo comparator	Drug: Placebo - IVParticipants received placebo by intravenously.
Placebo SC	Placebo comparator	Drug: Placebo - SCParticipants received placebo by subcutaneously.

Who may qualify

Ages: 20 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Are overtly healthy males or females, as determined by medical history and physical examination.
Are first generation Japanese or are Caucasian.
Have a body mass index (BMI) of 18.0 kilograms per square meter (kg/m2) to 32.0 kg/m2, inclusive, at screening.
Have a body weight of 40.0 kg or higher for Cohorts 1, 2, 3 and 4, and 48.0 kg or higher for Cohort 5 and 6.

Key exclusion criteria (5 listed)

Have had symptomatic herpes zoster within 3 months of screening.
Show evidence of active or latent tuberculosis (TB), as documented by medical history and examination, chest x-rays (posterior anterior and lateral), and TB testing.
Have received live vaccine(s) within 1 month of screening or intend to during the study.
Are immunocompromised.
Have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.

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 - IVAlso: LY3074828Administered IV	Drug	Mirikizumab IV
Mirikizumab - SCAlso: LY3074828Administered SC	Drug	Mirikizumab SC
Placebo - IVAdministered IV	Drug	Placebo 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 85
SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason

2 secondary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration
Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab
Time frame: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administration

Results and safety

Results posted to the registry on 8 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Subcutaneous (SC)	2	2
Placebo IV	10	8
60mg Mirikizumab IV	6	6
200mg Mirikizumab SC	6	6
200mg Mirikizumab IV	6	6
600mg Mirikizumab IV	9	8
1200mg Mirikizumab IV	6	6
2400mg Mirikizumab IV	6	6

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 85. Count of participants. Unit: Participants

Measure	Placebo SC n = 2	Placebo IV n = 10	60mg Mirikizumab IV n = 6	200mg Mirikizumab IV n = 6	200mg Mirikizumab SC n = 6	600mg Mirikizumab IV n = 9	1200mg Mirikizumab IV n = 6	2400mg Mirikizumab IV n = 6
Value	0	0	0	0	0	0	0	0

Population analysed: All randomized participants.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 88 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo SC	0 of 2 (0%)	2 of 2 (100%)	0 of 2
Placebo IV	0 of 10 (0%)	5 of 10 (50%)	0 of 10
60mg Mirikizumab IV	0 of 6 (0%)	3 of 6 (50%)	0 of 6
200mg Mirikizumab SC	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
200mg Mirikizumab IV	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
600mg Mirikizumab IV	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9
1200mg Mirikizumab IV	0 of 6 (0%)	0 of 6 (0%)	0 of 6
2400mg Mirikizumab IV	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 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 9AM - 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 - IV and Mirikizumab - 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 4 inclusion and 5 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 8 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 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?

Yes. Results are posted in the registry (first posted 8 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?

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 85). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02568423.

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 8 Feb 2024.