HealthyPhase 1NCT04137380

A Study of Mirikizumab in Healthy Chinese Participants

A Phase 1 study testing Mirikizumab - IV and Mirikizumab - SC in people with Healthy, run by Eli Lilly and Company at 2 sites in China.

Completed

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

Official record

Search all trials

Trial summary

The main purpose of this study is to evaluate the safety of the study drug known as mirikizumab. The study will investigate how the body processes the study drug. It will last up to about 4 months for each participant. 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 - 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: 60 participants
Where: 2 sitesChina
Study dates: 4 Dec 2019to 11 Dec 2020
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

Native Chinese (all 4 biological grandparents and both biological parents to be Chinese origin)
Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at time of screening
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
Have venous access sufficient to allow for blood sampling and administration of investigational product (IP) or placebo
Are reliable and willing to be available for the duration of the study and are willing to follow study procedures
Are able and willing to give signed informed consent

Who cannot join

Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated in a clinical trial involving an IP within 30 days or 5 half-lives (whichever is longer) prior to screening. If the clinical trial involved treatment with biologic agents (such as monoclonal antibodies, including marketed drugs), at least 3 months or 5 half-lives (whichever is longer) should have elapsed prior to Day 1
Have known allergies to LY3074828, humanized monoclonal antibodies, related compounds or any components of the formulation, or history of significant atopy
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen or positive hepatitis B core antibody

Show all 11Show fewer

Have had symptomatic herpes zoster within 3 months of screening
Show evidence of active or latent tuberculosis (TB), as documented by medical history, examination, chest X-rays (posterior/anterior and lateral), and TB testing (positive or indeterminate for QuantiFERON® -TB Gold test or T-Spot. 1 retest permitted following indeterminate result); or have had household contact with a person with active TB, unless appropriate and documented prophylaxis treatment has been given. Participants with any history of active TB are excluded from the study, regardless of previous or current TB treatments.
Have received live vaccine(s), including attenuated live vaccines and those administered intranasally, within 8 weeks of screening, or intend to during the study
Are immunocompromised
Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)

Trial locations and contacts

2 sites in 1 country.

China2 sites

Peking University First Hospital
Beijing, 100034
Shanghai Xuhui Central Hospital
Xuhui District, Shanghai Municipality, 20031

Other trials in China

About this study

Official title: A Single-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of LY3074828 in Healthy Chinese 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 NCT04137380
Study group	Role	What they receive
Mirikizumab - Intravenous (IV)	Experimental	Participants received a single dose of 300 milligram (mg), 600 mg and 1200 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes, 60 minutes and 2 hours. Receives: Drug: Mirikizumab - IV
Placebo - IV	Placebo comparator	Participants received a single dose of placebo administered IV using a forearm vein. Receives: Drug: Placebo - IV
Mirikizumab - Subcutaneous (SC)	Experimental	Participants received a single dose of 200 mg, 400 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). Receives: Drug: Mirikizumab - SC
Placebo - SC	Placebo comparator	Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right). 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 Drug-Related Treatment-Emergent Adverse Events (TEAEs)
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Measured: Baseline through Day 85
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Measured: 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection

Secondary outcomes (3)

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
PK: Cmax of Mirikizumab was evaluated.
Measured: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
PK: AUC(0-∞) of Mirikizumab was evaluated.
Measured: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab
PK: AUC(0-tlast) of Mirikizumab was evaluated.
Measured: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose

Timeline

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

4 Dec 201911 Dec 2020

First posted24 Oct 2019
Study start4 Dec 2019
Primary completion11 Dec 2020
Study completion11 Dec 2020

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: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04137380
Sponsor's protocol ID: 16766
Other IDs: I6T-MC-AMBD
Status last verified: May 2023
First submitted: 22 Oct 2019
Last updated: 26 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 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 Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT04137380
Acronym / sponsor ID: 16766
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 4 Dec 2019 (actual)
Primary completion: 11 Dec 2020 (actual)
Study completion: 11 Dec 2020 (actual)
First posted: 24 Oct 2019 (actual)
Results: Posted 26 Jan 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 - Intravenous (IV)	Experimental	Drug: Mirikizumab - IVParticipants received a single dose of 300 milligram (mg), 600 mg and 1200 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes, 60 minutes and 2 hours.
Placebo - IV	Placebo comparator	Drug: Placebo - IVParticipants received a single dose of placebo administered IV using a forearm vein.
Mirikizumab - Subcutaneous (SC)	Experimental	Drug: Mirikizumab - SCParticipants received a single dose of 200 mg, 400 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
Placebo - SC	Placebo comparator	Drug: Placebo - SCParticipants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Native Chinese (all 4 biological grandparents and both biological parents to be Chinese origin)
Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive, at time of screening
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
Have venous access sufficient to allow for blood sampling and administration of investigational product (IP) or placebo
Are reliable and willing to be available for the duration of the study and are willing to follow study procedures

Key exclusion criteria (11 listed)

Are currently enrolled in a clinical study involving an IP or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated in a clinical trial involving an IP within 30 days or 5 half-lives (whichever is longer) prior to screening. If the clinical trial involved treatment with biologic agents (such as monoclonal antibodies, including marketed drugs), at least 3 months or 5 half-lives (whichever is longer) should have elapsed prior to Day 1
Have known allergies to LY3074828, humanized monoclonal antibodies, related compounds or any components of the formulation, or history of significant atopy
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody

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 - Intravenous (IV)
Mirikizumab - SCAlso: LY3074828Administered SC	Drug	Mirikizumab - Subcutaneous (SC)
Placebo - IVAdministered IV	Drug	Placebo - IV
Placebo - SCAdministered SC	Drug	Placebo - SC

Primary outcome

Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs)
Time frame: Baseline through Day 85
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
Time frame: 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (>30 and ≤70), and severe pain (>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).

3 secondary outcomes

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose
PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab
Time frame: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdose

Results and safety

Results posted to the registry on 26 Jan 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 Intravenous (IV)	6	6
300 Milligram (mg) Mirikizumab IV	10	10
600 mg Mirikizumab IV	10	10
1200 mg Mirikizumab IV	10	9
Placebo Subcutaneous (SC)	4	4
200 mg Mirikizumab SC	10	10
400 mg Mirikizumab SC	10	10

Primary outcome: Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs)

Time frame: Baseline through Day 85. Number. Unit: participants

Measure	Placebo IV n = 6	300 mg Mirikizumab IV n = 10	600 mg Mirikizumab IV n = 10	1200 mg Mirikizumab IV n = 10	Placebo SC n = 4	200 mg Mirikizumab SC n = 10	400 mg Mirikizumab SC n = 10
Value	1	3	4	1	1	0	0

Population analysed: All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.

Primary outcome: Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site

Time frame: 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injection. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Placebo SC n = 4	200 mg Mirikizumab SC n = 10	400 mg Mirikizumab SC n = 10
0 min	36.5 (36.3)	30.8 (29.5)	42.4 (26.0)
0.25 h	3.5 (3.3)	2.9 (3.7)	10.6 (20.2)
0.5 h	2.3 (2.6)	1.9 (3.4)	9.5 (23.1)
1 h	1.0 (0.8)	1.6 (1.9)	2.0 (1.8)
2 h	1.8 (1.0)	1.2 (1.5)	2.0 (2.0)
4 h	1.0 (0.8)	1.0 (1.2)	2.1 (2.6)

Population analysed: All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment. As per statistical analysis plan, VAS pain score was analyzed only for SC dose.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up To 85 Days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo IV	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
300 mg Mirikizumab IV	0 of 10 (0%)	7 of 10 (70%)	0 of 10
600 mg Mirikizumab IV	0 of 10 (0%)	9 of 10 (90%)	0 of 10
1200 mg Mirikizumab IV	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Placebo SC	0 of 4 (0%)	3 of 4 (75%)	0 of 4
200 mg Mirikizumab SC	0 of 10 (0%)	4 of 10 (40%)	0 of 10
400 mg Mirikizumab SC	0 of 10 (0%)	5 of 10 (50%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

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

2 sites 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 2 sites in China.

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 6 inclusion and 11 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 26 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 26 Jan 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 Drug-Related Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline through Day 85). The study lists 2 primary outcomes in all. 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 NCT04137380.

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 26 Jan 2024.