Evidence map›Paper›PMID 40900263›Full record

Trial reportAdvances in therapy2025

Pharmacokinetic Bridging Between an Autoinjector and a Prefilled Syringe Following Subcutaneous Administration of Mirikizumab in Healthy Participants.

Xin Zhang, Yuki Otani, Christopher D Payne, Nathan J Morris, Laiyi Chua, Rodrigo Escobar, Sihe Wang, Galen Shi

2 registry-linked trialsAbstract readRandomized Controlled TrialClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04607733 phase1completednot on this map

A Bioequivalence Study of Injections of Mirikizumab Solution Using an Investigational 1-mL Pre-Filled Syringe and an Investigational 1-mL Autoinjector in Healthy Participants

TypeinterventionalSponsorEli Lilly and CompanyRan2020 to 2021Enrolled240ConditionsHealthyArmsMirikizumab Prefilled Syringe, Mirikizumab Autoinjector
NCT05069896 phase1completednot on this map

A Bioequivalence Study of Injections of Mirikizumab Solution Using Investigational 1-mL and 2-mL Pre-Filled Syringes and Investigational 1-mL and 2-mL Autoinjectors in Healthy Participants

TypeinterventionalSponsorEli Lilly and CompanyRan2021 to 2022Enrolled237ConditionsHealthyArmsMirikizumab Prefilled Syringe, Mirikizumab Autoinjector
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Xin ZhangEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA. zhang_xin_xz@lilly.com.ORCID http://orcid.org/0000-0002-4064-6805
Yuki OtaniEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.ORCID http://orcid.org/0000-0002-7184-8776
Christopher D PayneEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.ORCID http://orcid.org/0000-0003-0549-5455
Nathan J MorrisEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.ORCID http://orcid.org/0000-0001-7989-5764
Laiyi ChuaEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.ORCID http://orcid.org/0009-0003-5417-3062
Rodrigo EscobarEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.
Sihe WangEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.
Galen ShiEli Lilly and Company, Lilly Corporate Center, 893 Delaware Street, Indianapolis, IN, 46225, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMirikizumab, a humanized anti-interleukin-23p19 monoclonal antibody, is approved for the treatment of moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD). Two phase 1, open-label, two-arm, randomized studies compared pharmacokinetics and safety of mirikizumab (200 mg, Study AMBW; 300 mg, Study AMBX) to establish bioequivalence. Mirikizumab was administered subcutaneously using an autoinjector or a prefilled syringe (PFS) as a single dose in healthy participants.

methodsParticipants (male and female) were randomized 1:1 to mirikizumab by a PFS (reference) and an autoinjector (test). Participants were sub-randomized (1:1:1) to one of three injection sites (abdomen, arm, thigh) and stratified into one of three weight groups. Primary endpoints were maximum observed drug concentration (C

resultsIn Study AMBW, 90% confidence intervals (CIs) for the ratios (autoinjector to PFS) of geometric least squares mean values for C

conclusionMirikizumab administered by autoinjector or PFS was considered bioequivalent at the 200-mg UC maintenance dose and the 300-mg CD maintenance dose. Safety and immunogenicity profiles were comparable between autoinjector and PFS. Availability of an autoinjector option may be preferred by some patients and may help improve patient adherence to treatment. CLINICAL

trial registrationClinicalTrials.gov NCT04607733; NCT05069896.

Indexed as

Antibodies, Monoclonal, HumanizedAdultArea Under CurveFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedSyringesTherapeutic EquivalencyYoung AdultAntibodies, Monoclonal, HumanizedAutoinjectorBioequivalenceColitisCrohn’s diseaseMirikizumabPharmacokineticsPrefilled syringeUlcerative

Identifiers

PMID40900263
PMCPMC12579708

What Socratic holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.