Evidence map›Paper›PMID 40913454›Full record

Trial reportJournal of clinical pharmacology2026

A Phase 1 Randomized Study: Garadacimab Pharmacokinetics, Safety, and Tolerability After Administration via Autoinjector/Pre-Filled Pen Versus Pre-Filled Syringe in Healthy Participants.

Fiona Glassman, John-Philip Lawo, Mihai Alexandru Bica, Anthony Roberts, David Kormann, Ligia Chialda, Soeren Miethke, Iwona Dziadowiec, Stephen Caltabiano, Thomas Puchalski

Abstract readRandomized Controlled TrialClinical Trial, Phase IComparative Study
In one paragraph

Trial report in Journal of clinical pharmacology, 2026. 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. 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

10 authors.

Fiona GlassmanCSL Behring LLC, King of Prussia, PA, USA.
John-Philip LawoCSL Behring Innovation GmbH, Marburg, Germany.
Mihai Alexandru BicaCSL Behring Innovation GmbH, Marburg, Germany.
Anthony RobertsCSL Innovation Pty Ltd., Parkville, Victoria, Australia.
David KormannCSL Behring LLC, King of Prussia, PA, USA.
Ligia ChialdaCSL Behring AG, Bern, Switzerland.
Soeren MiethkeCSL Behring AG, Bern, Switzerland.
Iwona DziadowiecCSL Behring AG, Bern, Switzerland.
Stephen CaltabianoCSL Behring LLC, King of Prussia, PA, USA.
Thomas PuchalskiCSL Behring LLC, King of Prussia, PA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Garadacimab is a novel, fully human, anti-activated factor XII monoclonal antibody approved for long-term prophylaxis of patients with hereditary angioedema. This open-label, parallel-group, Phase 1, single-center, bridging study in healthy adults (18-55 years of age) characterized the pharmacokinetics and safety of a single 200 mg subcutaneous injection of garadacimab administered via autoinjector/pre-filled pen (AI/PFP) compared with the pre-filled syringe (PFS) used in previous studies. The aim of the study was to bridge the understanding of the PK and safety of garadacimab between PFS and AI/PFP modes of administration. Participants (N = 132) were stratified by body weight, randomized evenly in six groups by device (AI/PFP or PFS) and injection site (abdomen, thigh, or upper arm). The primary endpoint comprised pharmacokinetic parameter comparison between devices. Safety/tolerability were secondary endpoints. The geometric mean ratio (GMR) for C

Indexed as

Antibodies, Monoclonal, HumanizedAdolescentAdultArea Under CurveFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedSyringesYoung AdultAntibodies, Monoclonal, Humanizedgaradacimabautoinjectorgaradacimabhereditary angioedemahome useinjectionsmonoclonal antibody

Identifiers

PMID40913454
PMCPMC12706687

What Socratic holds

Textmetadata
LicenceCC BY-NC
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.