Immunotherapy · 2025
Pharmacokinetics and safety of CT‑P39 via auto-injector are comparable to reference omalizumab via pre-filled syringe.
СтатьяКлиническое исследование I фазыРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Hasunuma Tomoko, Grattan Clive, Eto Takashi, Yagi Michio, Yazawa Rie, Kim Sunghyun, Bae Yunju, Kim Suyoung, Park Jeong Eun, Kim Jongho, Saini Sarbjit
Аннотация
AIMS: To demonstrate pharmacokinetic equivalence of CT‑P39 administered via auto-injector (CT‑P39 AI) and European Union-approved reference omalizumab via pre-filled syringe (EU-OMA PFS) in healthy Japanese adults.
PARTICIPANTS & METHODS: This open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80-125% equivalence margin. Secondary endpoints comprised additional pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
RESULTS: Overall, 65 and 64 individuals were randomized to CT‑P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT‑P39 AI and EU-OMA PFS was demonstrated for both AUC0-inf (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and Cmax (93.91 [87.20-101.14]). Thirty-nine (60.0%; CT‑P39 AI) and 32 (50.8%; EU-OMA PFS) participants experienced treatment-emergent adverse events (TEAEs) with no serious TEAEs. Secondary endpoints were comparable between groups.
CONCLUSIONS: CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.
PARTICIPANTS & METHODS: This open-label, Phase 1 study randomized participants (1:1) to a single 150 mg/mL dose of CT‑P39 AI or EU-OMA PFS. The primary endpoint was pharmacokinetic equivalence per area under the concentration-time curve from time zero to infinity (AUC0-inf) and maximum serum concentration (Cmax). Equivalence was concluded if the 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were contained within the predefined 80-125% equivalence margin. Secondary endpoints comprised additional pharmacokinetics, pharmacodynamics, safety, and immunogenicity.
RESULTS: Overall, 65 and 64 individuals were randomized to CT‑P39 AI and EU-OMA PFS, respectively. Pharmacokinetic equivalence between CT‑P39 AI and EU-OMA PFS was demonstrated for both AUC0-inf (ratio of gLSMs [90% CI] 101.66 [95.31-108.45]) and Cmax (93.91 [87.20-101.14]). Thirty-nine (60.0%; CT‑P39 AI) and 32 (50.8%; EU-OMA PFS) participants experienced treatment-emergent adverse events (TEAEs) with no serious TEAEs. Secondary endpoints were comparable between groups.
CONCLUSIONS: CT‑P39 AI was pharmacokinetically equivalent to EU-OMA PFS following a single dose in healthy Japanese individuals; pharmacodynamics, safety, and immunogenicity were comparable.