Evidence map›Paper›PMID 39582204›Full record

ArticleJournal of clinical pharmacology2025

Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous and Intravenous Garadacimab Following Single-Dose Administration in Healthy Japanese and White Adults.

Fiona Glassman, John-Philip Lawo, Mihai Alexandru Bica, Anthony Roberts, Dipti Pawaskar, Hideto Akama, Meena Jain, Summer Goodson

Abstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Review
  2. Article
  3. 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.

Fiona GlassmanCSL Behring LLC, King of Prussia, Pennsylvania, USA.ORCID 0000-0002-1292-6332
John-Philip LawoCSL Innovation GmbH, Marburg, Germany.
Mihai Alexandru BicaCSL Innovation GmbH, Marburg, Germany.
Anthony RobertsCSL Innovation Pty Ltd, Parkville, Victoria, Australia.
Dipti PawaskarRegeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Hideto AkamaCSL Behring, Tokyo, Japan.
Meena JainAkero Therapeutics, South San Francisco, California, USA.
Summer GoodsonEMD Serono, Inc., Rockland, Massachusetts, USA.

Funding

CSL Behring LLC
6 · The paper itself

Abstract

Garadacimab, an activated factor XII (FXIIa) inhibitor monoclonal antibody, is being evaluated for the long-term prophylaxis of hereditary angioedema. Here, we report the results from a two-part, phase 1, open-label, single ascending dose study assessing the pharmacokinetics (PK), pharmacodynamics, safety, and tolerability after subcutaneous (SC) and intravenous (IV) administration of garadacimab in healthy Japanese and White participants. Part 1 assessed garadacimab PK after SC administration of a 200 mg dose in weight-matched White and Japanese participants, and 600 mg dose in Japanese participants. Part 2 assessed 3 and 10 mg/kg IV doses in Japanese participants. Follow-up for safety was over 84 days post-dose. Overall, 37 participants received garadacimab dosing and 36 completed the study, with one participant lost to follow-up. Following SC administration, time to maximum plasma concentration (t

Indexed as

Antibodies, MonoclonalAntibodies, Monoclonal, HumanizedAdministration, IntravenousAdultArea Under CurveDose-Response Relationship, DrugEast Asian PeopleFemaleHumansInfusions, IntravenousInjections, SubcutaneousMaleMiddle AgedWhite PeopleYoung AdultAntibodies, MonoclonalAntibodies, Monoclonal, Humanizedactivated factor XIIangioedemagaradacimabpharmacodynamicspharmacokineticssafety

Identifiers

PMID39582204
PMCPMC11937999

What OpenQuestion holds

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LicenceCC BY-NC
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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.