Trial reportJournal of clinical pharmacology2026
First-in-Human Dose Selection and Safety, Tolerability, Pharmacokinetics, and Immunogenicity of the Muscle-Specific Kinase Agonist Adimanebart (ARGX-119).
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.
What it found
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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.
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.
Who cites it
1 citing paper in PubMed.
- Spinal muscular atrophy: Biology, pathogenesis, and therapeutic advances.Therapeutic advances in neurological disorders · 2026Review
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Adimanebart (ARGX-119), a first-in-class, humanized, agonistic monoclonal antibody, specifically targets and activates muscle-specific kinase, stabilizing the neuromuscular junction, increasing muscle strength, and decreasing muscle weakness and fatigability in nonclinical, proof-of-concept studies. Adimanebart may have broad therapeutic potential in neuromuscular junction disorders. This Phase I, first-in-human, double-blinded, placebo-controlled study assessed the safety, tolerability, pharmacokinetics, and immunogenicity of adimanebart in healthy participants. With no pharmacodynamic marker for muscle-specific kinase dimerization by adimanebart, human dose predictions were based on the minimum anticipated biological effect level in nonclinical studies. In this two-part study, 112 healthy participants were randomized to receive adimanebart or placebo in single ascending intravenous doses (0.005-15 mg/kg) or a single subcutaneous dose (5 mg/kg; Part A; n = 76), or weekly multiple ascending intravenous doses (0.3-5 mg/kg; Part B; n = 36). Adimanebart was well tolerated with a favorable safety profile. In single-ascending dose (SAD) cohorts, adimanebart demonstrated nonlinear pharmacokinetics at low concentrations, a dose-proportional increase in maximum concentration (mean range: 0.1-343 µg/mL), and a ≈6-fold increase in area under the concentration-time curve (0 to infinity) following a single intravenous dose, indicating target-mediated drug disposition. Incidence and prevalence of adimanebart anti-drug antibodies were comparable between treatment groups in SAD cohorts (adimanebart: 16.0% and 18.0%, placebo: 16.7% and 22.2%, respectively) and were not detected in multiple-ascending-dose cohorts. There was no apparent impact of anti-drug antibodies on adimanebart pharmacokinetics or safety. This study supports investigation of adimanebart as an agonistic muscle-specific kinase monoclonal antibody treatment for neuromuscular junction disorders.
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