Evidence map›Paper›PMID 33047859›Full record

Trial reportBritish journal of clinical pharmacology2021

Safety, pharmacokinetics and pharmacodynamics of BI 655064 in phase 1 clinical trials in healthy Chinese and Japanese subjects.

Yasuhiro Tsuda, Christine Grimaldi, Fenglei Huang, Ewald Benediktus, Nobutaka Yagi, Steven J Padula, In-Jin Jang, Jürgen Steffgen

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

Trial report in British journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
  4. CD40-CD40L in Neurological Disease.International journal of molecular sciences · 2022
    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

8 authors.

Yasuhiro TsudaNippon Boehringer Ingelheim Co. Ltd, Kobe, Japan.
Christine GrimaldiBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Fenglei HuangBoehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT, USA.
Ewald BenediktusBoehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.
Nobutaka YagiNippon Boehringer Ingelheim Co. Ltd, Tokyo, Japan.
Steven J PadulaBoehringer Ingelheim International GmbH, Ingelheim, Germany.
In-Jin JangSeoul National University Hospital Clinical Trials Center, Seoul, Korea.
Jürgen SteffgenBoehringer Ingelheim International GmbH, Biberach, Germany.

Funding

Boehringer Ingelheim
6 · The paper itself

Abstract

aimsTo evaluate the safety, pharmacokinetics and pharmacodynamics of BI 655064 in healthy Chinese and Japanese subjects after administration of single doses of 80-240 mg and multiple dosing of 240 mg once weekly over 4 weeks.

methodsTwo phase 1, double-blind, placebo-controlled studies were conducted (single-rising doses of BI 655064 in Chinese/Japanese male subjects [n = 12 per BI 655064 dose group] or repeated 240 mg BI 655064 in Chinese male subjects [n = 9]). Plasma samples were collected to investigate BI 655064 pharmacokinetics, pharmacodynamics (CD40 receptor occupancy [RO]) and immunogenicity, along with the safety and tolerability of BI 655064.

resultsBI 655064 showed good overall tolerability following single-dose administration of 80-240 mg and repeated administration of 240 mg BI 655064 over 4 weeks. More Chinese subjects reported adverse events compared with Japanese subjects following single-dose administration (59.4% vs 3.1%). BI 655064 exhibited nonlinear, saturable kinetics, with higher doses resulting in slower apparent clearance (0.514-0.713 mL min

conclusionsBI 655064 pharmacokinetic and safety profiles in East Asian male subjects were consistent with those observed in a Western population. No adjustments in the BI 655064 dosing recommendations are warranted for future clinical trials.

Indexed as

Area Under CurveAntibodies, Monoclonal, HumanizedChinaDose-Response Relationship, DrugDouble-Blind MethodHealthy VolunteersHumansJapanMaleAntibodies, Monoclonal, HumanizedBI 655064antibodyanti-CD40East Asianhealthylupusmonoclonalpharmacokinetics

Identifiers

PMID33047859
PMCPMC8056730

What OpenQuestion holds

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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 OpenQuestion graph.