Evidence map›Paper›PMID 33503313›Full record

Trial reportClinical and translational science2021

Pharmacokinetic equivalence of CT-P17 to high-concentration (100 mg/ml) reference adalimumab: A randomized phase I study in healthy subjects.

Kyung-Sang Yu, In-Jin Jang, Hyeong-Seok Lim, Jang Hee Hong, Min-Gul Kim, Min Kyu Park, Doo-Yeoun Cho, Min Soo Park, Jae Yong Chung, Jong-Lyul Ghim and 10 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IEquivalence TrialMulticenter Study
In one paragraph

Trial report in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03970824 (A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 25% of its field
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.

NCT03970824 phase1completednot on this map

A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US-licensed Humira and EU-approved Humira) in Healthy Subjects

TypeinterventionalSponsorCelltrionRan2019 to 2020Enrolled312ConditionsHealthyArmsCT-P17, US-licensed Humira, EU-approved Humira
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

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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

20 authors at 14 institutions in 4 countries.

Kyung-Sang YuSeoul National University College of Medicine and Hospital, Seoul, Korea.
In-Jin JangSeoul National University College of Medicine and Hospital, Seoul, Korea.
Hyeong-Seok LimAsan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
Jang Hee HongChungnam National University Hospital, Daejeon, Korea.
Min-Gul KimCollege of Medicine, Jeonbuk National University, Jeonbuk, Korea.
Min Kyu ParkChungbuk National University Hospital, Cheongju, Korea.
Doo-Yeoun ChoCHA Bundang Medical Center, CHA University, Seongnam, Korea.
Min Soo ParkSeverance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Jae Yong ChungSeoul National University Bundang Hospital, Seongnam, Korea.
Jong-Lyul GhimInje University Busan Paik Hospital, Busan, Korea.
SeungHwan LeeSeoul National University College of Medicine and Hospital, Seoul, Korea.
Seok Kyu YoonAsan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.
In Sun KwonChungnam National University Hospital, Daejeon, Korea.
Sang Joon LeeCelltrion, Inc., Incheon, Korea.
Sung Hyun KimCelltrion, Inc., Incheon, Korea.
Yun Ju BaeCelltrion, Inc., Incheon, Korea.
Jung Bin ChaCelltrion, Inc., Incheon, Korea.
Daniel E FurstUniversity of California, Los Angeles, California, USA.
Edward KeystoneMount Sinai Hospital, University of Toronto, Toronto, Canada.
Jonathan KayUniversity of Massachusetts Medical School and UMass Memorial Medical Center, Worcester, Massachusetts, USA.
Celltrion (South Korea) · KRChungnam National University Hospital · KRSeoul National University Hospital · KRAsan Medical Center · KRCHA University · KRChungbuk National University Hospital · KRInje University Busan Paik Hospital · KRJeonbuk National University · KRMount Sinai Hospital · CASeoul National University Bundang Hospital · KRSeverance Hospital · KRUMass Memorial Medical Center · USUniversity of Florence · ITUniversity of Ulsan · KR

Funding

Celltrion, Inc.
6 · The paper itself

Abstract

This study aimed to demonstrate pharmacokinetic (PK) equivalence of a single dose of the proposed adalimumab biosimilar CT-P17 to United States-licensed adalimumab (US-adalimumab) and European Union-approved adalimumab (EU-adalimumab). This double-blind, parallel-group, phase I trial (clinicaltrials.gov NCT03970824) was conducted at 10 hospitals (Republic of Korea), in which healthy subjects (1:1:1) were randomized to receive a single 40 mg (100 mg/ml) subcutaneous injection of CT-P17, US-adalimumab, or EU-adalimumab. Primary end points were PK equivalence in terms of: area under the concentration-time curve from time zero to infinity (AUC

Indexed as

AdalimumabBiosimilar PharmaceuticalsTumor Necrosis Factor InhibitorsAdultAntibodies, Monoclonal, HumanizedArea Under CurveDouble-Blind MethodFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedRepublic of KoreaTherapeutic EquivalencyYoung AdultAdalimumabAntibodies, Monoclonal, HumanizedBiosimilar PharmaceuticalsCT-P17Tumor Necrosis Factor Inhibitors

Identifiers

PMID33503313
PMCPMC8301575
OpenAlexW3124773781

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.