Evidence map›Paper›PMID 41710946›Full record

Trial reportClinical pharmacology in drug development2026

Bioequivalence Between a Gantenerumab Disposable Syringe and an Autoinjector: A Randomized Controlled Trial in Healthy Volunteers.

Dietmar Schwab, Carsten Hofmann, Nicole Justies, Daniel S Dickerson, Ali Keshavarz, Thijs van Iersel, Kimberly Martens, Beate Bittner

Abstract readRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Clinical pharmacology in drug development, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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.

Dietmar SchwabPharma Research and Early Development, Pharmaceutical Sciences, Roc, he Innovation Center, Basel, Switzerland.
Carsten HofmannPharma Research and Early Development, Pharmaceutical Sciences, Roc, he Innovation Center, Basel, Switzerland.
Nicole JustiesPharma Research and Early Development, Pharmaceutical Sciences, Roc, he Innovation Center, Basel, Switzerland.
Daniel S DickersonICON - Early Development Services, Lenexa, KS, USA.
Ali KeshavarzICON - Early Development Services, Lenexa, KS, USA.
Thijs van IerselICON - Early Development Services, Groningen, The Netherlands.
Kimberly MartensICON - Early Development Services, Lenexa, KS, USA.
Beate BittnerGlobal Pharma Strategy, Product Optimization, Basel, Switzerland.

Funding

F. Hoffmann-La Roche
6 · The paper itself

Abstract

Gantenerumab, a monoclonal antibody targeting amyloid beta plaques in the brain, reduces plaque accumulation and was developed to slow Alzheimer's disease progression. Results from the pivotal GRADUATE I and II studies evaluating gantenerumab in people with early Alzheimer's disease were announced in 2022. The studies did not meet their primary endpoint of slowing clinical decline. This study evaluated the pharmacokinetics, immunogenicity, and safety of a high concentration liquid formulation of gantenerumab administered subcutaneously as a single dose using an autoinjector (AI) or a disposable syringe (DS). The DS was employed in pivotal clinical trials, while the AI was developed in parallel to ease SC administration. The study aimed to demonstrate bioequivalence (BE) between AI and DS administration in healthy participants, defined by 90% confidence intervals (CIs) for geometric least square (LS) mean ratios being within the 0.80-1.25 range for maximum observed plasma concentration (C

Indexed as

Antibodies, Monoclonal, HumanizedSyringesAdultArea Under CurveDisposable EquipmentFemaleHealthy VolunteersHumansInjections, SubcutaneousMaleMiddle AgedTherapeutic EquivalencyYoung AdultAntibodies, Monoclonal, Humanizedautoinjectorbioequivalencedevice bridging

Identifiers

PMID41710946
PMCPMC12919677

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.