P.106 Investigating the bioequivalence, injection speed, and usability of subcutaneous efgartigimod PH20 administration using a prefilled syringe
Bibliographic record
Abstract
Background: Efgartigimod, a human immunoglobulin G1 (IgG1) antibody Fc fragment, reduces IgG levels through neonatal Fc receptor blockade. Efgartigimod PH20 SC (1000-mg fixed dose, coformulated with recombinant human hyaluronidase PH20) is provided in a vial administered via a separate syringe (V+S). Here, we investigate bioequivalence, safety, and tolerability of efgartigimod PH20 SC administered via prefilled syringe (PFS) vs V+S in healthy participants. Methods: Bioequivalence was assessed in a phase 1, open-label study. Healthy participants (n=72) were randomized to receive one injection of efgartigimod PH20 SC via PFS or V+S in a crossover design. Separate studies evaluated feasibility of different injection speeds and usability of the PFS. Results: Bioequivalence between efgartigimod PH20 SC via PFS or V+S was established, as the 90% CI around the geometric least-squares mean ratio of C max and AUC 0-inf was within predefined criteria (80.00%-125.00%). Most adverse events were mild to moderate. No observed differences in incidence of reported injection site reactions emerged. No serious adverse events or deaths occurred. Rapid (20-second) administration was feasible and the PFS could be safely prepared and administered by participants/caregivers. Conclusions: Efgartigimod PH20 SC administered via PFS is bioequivalent to efgartigimod PH20 SC administered via V+S, which may provide an additional convenient treatment option.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.003 | 0.009 |
| Scholarly communication | 0.000 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; both teacher heads agree on what is shown here.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".