Evidence map›Paper›PMID 40017397›Full record

Trial reportImmunotherapy2025

Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.

Tomoko Hasunuma, Clive Grattan, Takashi Eto, Michio Yagi, Rie Yazawa, Sunghyun Kim, Yunju Bae, Suyoung Kim, Jeong Eun Park, Jongho Kim and 1 more

Abstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Immunotherapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. CT-P39: An Omalizumab Biosimilar.Clinical drug investigation · 2026
    Review
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

11 authors.

Tomoko HasunumaDepartment of Research, Clinical Trial Center, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Clive GrattanSt John's Institute of Dermatology, Guy's Hospital, London, UK.
Takashi EtoSOUSEIKAI Hakata Clinic, Fukuoka, Japan.
Michio YagiMedical Corporation Heishinkai OPHAC Hospital, Osaka, Japan.
Rie YazawaClinical Pharmacology Center, SOUSEIKAI Sumida Hospital, Tokyo, Japan.
Sunghyun KimMedical Science Division, Celltrion, Inc., Incheon, Republic of Korea.
Yunju BaeClinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
Suyoung KimClinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
Jeong Eun ParkClinical Planning Department, Celltrion, Inc., Incheon, Republic of Korea.
Jongho KimClinical Statistics Department, Celltrion, Inc., Incheon, Republic of Korea.
Sarbjit SainiDepartment of Medicine, Division of Allergy and Clinical Immunology, Johns Hopkins Asthma and Allergy Center, Baltimore, MD, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo demonstrate pharmacokinetic equivalence of CT‑P39 administered via auto-injector (CT‑P39 AI) and European Union-approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults. PARTICIPANTS &

methodsThis open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC

resultsOverall, 65 and 64 individuals were randomized to CT‑P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT‑P39 AI and EU-OMA PFS was demonstrated for both AUC

conclusionsCT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.

Indexed as

Anti-Asthmatic AgentsBiosimilar PharmaceuticalsOmalizumabAdultFemaleHumansMaleMiddle AgedSyringesTherapeutic EquivalencyYoung AdultAnti-Asthmatic AgentsBiosimilar PharmaceuticalsOmalizumabAuto-injectorbiosimilarCT‑P39immunogenicityomalizumabpharmacokineticsafetytherapeutic anti-IgE

Identifiers

PMID40017397
PMCPMC11901399

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.