Evidence map›Paper›PMID 40374841›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics2025

Pharmacokinetic Characterization of Cendakimab Administered with Different Devices and at Different Injection Sites in Healthy Participants.

Peijin Zhang, Claudia H M C De Oliveira, Kyungha Yu, Shenita Basdeo, Christina M Charriez, Mary Syto, Mark Thomas, Bindu Murthy

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IComparative Study
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05337345 (A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants), 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.

NCT05337345 phase1completednot on this map

A Phase I, Open-Label, Randomized, Two-part Parallel Study to Compare the Pharmacokinetics of Single Subcutaneous Injections of Cendakimab Administered Using Autoinjector Versus Using Prefilled Syringe, and to Evaluate the Pharmacokinetics of Cendakimab When Administered by Autoinjector at Different Injection Sites, in Healthy Participants

TypeinterventionalSponsorBristol-Myers SquibbRan2022 to 2022Enrolled104ConditionsHealthy VolunteersArmsCendakimab
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.

Peijin ZhangBristol Myers Squibb, Princeton, NJ, USA. Peijin.Zhang@bms.com.
Claudia H M C De OliveiraBristol Myers Squibb, Princeton, NJ, USA.
Kyungha YuBristol Myers Squibb, Princeton, NJ, USA.
Shenita BasdeoBristol Myers Squibb, Princeton, NJ, USA.
Christina M CharriezBristol Myers Squibb, Princeton, NJ, USA.
Mary SytoBristol Myers Squibb, Princeton, NJ, USA.
Mark ThomasBristol Myers Squibb, Princeton, NJ, USA.
Bindu MurthyBristol Myers Squibb, Princeton, NJ, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe cendakimab (CC-93538, previously RPC4046) phase 3 trial used prefilled syringes (PFS), while the intended commercial product is an autoinjector (AI). This study evaluated the pharmacokinetic (PK) comparability of cendakimab administration by PFS and AI, and at different injection sites.

methodsThis was a phase 1, single-center, randomized, open-label, single-dose, two-part parallel-group study (NCT05337345) in healthy adults. In part 1, participants were randomized 1:1 to receive cendakimab 360 mg subcutaneously in the abdomen by PFS (treatment A) or AI (treatment B). In part 2, participants were randomized to receive cendakimab 360 mg subcutaneously in either the upper arm (treatment C) or upper thigh area (treatment D) by AI. Analysis of covariance was used to compare the log-transformed area under the curve (AUC) and peak concentration (C

resultsOverall, 64 and 40 healthy adults were dosed in parts 1 and 2, respectively. In part 1, the geometric least squares mean (LSM) ratios (90% CI) of treatment B versus A were contained within the generally accepted limit of 80-125%; 1.04 (0.90-1.20), 0.98 (0.87-1.12), and 0.99 (0.87-1.12) for C

conclusionsPK parameters of cendakimab were comparable when using PFS or AI. Cendakimab exposures when administered in the arm or thigh resulted in similar exposure; both were ~ 20% higher than when administering in the abdomen. Both PFS and AI were well tolerated. ADA status did not impact the PK or safety of cendakimab. CLINICALTRIALS: GOV: NCT05337345.

Indexed as

Antibodies, Monoclonal, HumanizedAdultArea Under CurveFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedSyringesYoung AdultAntibodies, Monoclonal, Humanized

Identifiers

PMID40374841

What OpenQuestion holds

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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 OpenQuestion graph.