Randomised, phase I pharmacokinetic study of adalimumab biosimilar CT‐P17 (40 mg/0.4 mL) by autoinjector and prefilled syringe in healthy subjects
Bibliographic record
Abstract
Aims To evaluate pharmacokinetic equivalence and preliminary safety of the adalimumab biosimilar CT‐P17 administered via autoinjector (CT‐P17 AI) or prefilled syringe (CT‐P17 PFS) in healthy subjects. Methods This phase I, open‐label study ( ClinicalTrials.gov : NCT04295356) randomised subjects (1:1) to receive a single 40‐mg (100 mg/mL) dose of CT‐P17 AI or CT‐P17 PFS. Primary endpoint was pharmacokinetic equivalence of CT‐P17 AI to CT‐P17 PFS for: area under the concentration–time curve from time zero to infinity (AUC0–inf); area under the concentration–time curve from time zero to the last quantifiable concentration (AUC0–last); maximum serum concentration (Cmax). Equivalence was determined if the 90% confidence interval for the geometric least‐squares mean ratio was within the 80–125% equivalence margin. Additional pharmacokinetic endpoints, safety and immunogenicity were evaluated. Results Of 193 subjects who were randomised (98 CT‐P17 AI; 95 CT‐P17 PFS), 180 received study drug. Pharmacokinetic equivalence was demonstrated: 90% confidence intervals were within the 80–125% equivalence margin (AUC0–inf: 93.98–114.29; AUC0–last: 91.09–121.86; Cmax: 94.08–111.90). Mean serum CT‐P17 concentrations, secondary pharmacokinetic parameters and numbers of subjects with antidrug antibodies (ADAs) or neutralising ADAs were comparable between groups. AUC0–inf, AUC0–last and Cmax were numerically lower for ADA‐positive than for ADA‐negative subjects (both groups); pharmacokinetic equivalence was also demonstrated among ADA‐positive subjects. CT‐P17 AI and CT‐P17 PFS were well tolerated, with comparable overall safety profiles. Conclusions CT‐P17 AI and CT‐P17 PFS were pharmacokinetically equivalent. Overall safety and immunogenicity were comparable between the 2 delivery devices.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.004 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.002 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
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".