Evidence map›Paper›PMID 39636565›Full record

Trial reportAdvances in therapy2025

Pharmacokinetics, Pharmacodynamics, Bioavailability, and Immunogenicity of Obexelimab Following Subcutaneous Administration in Healthy Japanese and Non-Japanese Volunteers.

Xiaodong Wang, Rachel Kirk, Mark Matijevic, Minggeng Gao, Allen Poma, Shauna Quinn, Sujata Arora, Tanya Fischer

Registry-linked trialAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed 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 trial NCT02867098 (Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

NCT02867098 phase1completednot on this map

Pharmacokinetics and Relative Bioavailability of XmAb®5871 Administered Either Intravenously or Subcutaneously

TypeinterventionalSponsorXencor, Inc.Ran2016 to 2016Enrolled50ConditionsHealthy VolunteersArmsXmAb5871
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Xiaodong WangZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA. xiaodong.wang@zenasbio.com.
Rachel KirkZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Mark MatijevicZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Minggeng GaoZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Allen PomaZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Shauna QuinnZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Sujata AroraZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.
Tanya FischerZenas BioPharma, 1000 Winter St, Suite 1200, Waltham, MA, 02451, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionObexelimab is an investigational, bifunctional, non-depleting, humanized monoclonal antibody that binds CD19 and FcγRIIb to inhibit B cells, plasmablasts, and CD19-expressing plasma cells. In clinical trials, intravenous (IV) administration of obexelimab has been well-tolerated, and demonstrated clinical activity in patients with rheumatoid arthritis, systemic lupus erythematosus, and immunoglobulin G4-related disease. This study was performed to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of obexelimab following subcutaneous (SC) administration, and compare PK/PD profiles between healthy Japanese and non-Japanese volunteers.

methodsThis was a Phase I, open-label, parallel group, multiple-dose study. Participants were randomized to five cohorts to receive three doses of obexelimab as 125 mg SC every 14 days (q14d), 250 mg SC q14d, 375 mg SC q14d, 250 mg IV q14d, and 125 mg SC every 7 days, then monitored during a 28-day safety follow-up period. PK/PD assessments were performed after the first and third doses.

resultsA total of 50 healthy volunteers (25 Japanese and 25 non-Japanese) were enrolled and distributed evenly between dose cohorts. All SC dosing regimens were well-tolerated. Dose-proportional PK was observed following SC doses with a bioavailability of approximately 60%. No clinically meaningful differences in PK parameters were found between healthy Japanese and non-Japanese participants. Antidrug antibodies (ADA) were detected in 6/50 (12%) participants after dosing. ADA had no or minimal impact on PK in all six ADA positive participants. Near-complete CD19 receptor occupancy and an absolute B-cell count nadir of approximately 50% baseline levels were maintained for the duration of the study in both populations.

conclusionObexelimab SC administration demonstrated favorable bioavailability, was well-tolerated, and showed no clinically meaningful ethnic differences in PK/PD. These results support further clinical development of SC obexelimab to treat B-cell mediated autoimmune diseases.

trial registrationNCT02867098.

Indexed as

Antibodies, Monoclonal, HumanizedAdultAsian PeopleBiological AvailabilityDose-Response Relationship, DrugEast Asian PeopleFemaleHealthy VolunteersHumansInjections, SubcutaneousJapanMaleMiddle AgedYoung AdultAntibodies, Monoclonal, HumanizedAutoimmune diseasesB-cell inhibitionBispecific antibodyCD19 inhibitorEthnic bridging studyFcγRIIb inhibitorObexelimabPharmacokineticsSubcutaneous administrationTherapeutic antibodies

Identifiers

PMID39636565

What Socratic holds

Textmetadata
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.