A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CTP41 and reference denosumab in healthy males.
Expert Opin Biol Ther
; 24(7): 655-663, 2024 Jul.
Article
in En
| MEDLINE
| ID: mdl-38349618
ABSTRACT
BACKGROUND:
This study's objective was to demonstrate pharmacokinetic (PK) similarity and safety of denosumab biosimilar, CTP41, and United States-licensed reference denosumab (US-denosumab) in healthy male Asian adults, considering also pharmacodynamic (PD) outcomes. RESEARCH DESIGN ANDMETHODS:
This double-blind, two-arm, parallel-group, Phase 1 study randomized (11) healthy males to a single (60-mg) subcutaneous dose of CTP41 or US-denosumab. Primary endpoints were area under the concentration - time curve (AUC) from time zero to infinity (AUC0-inf), AUC from time zero to the last quantifiable concentration (AUC0-last), and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for ratios of geometric least-squares means (gLSMs) were within the predefined 80-125% equivalence margin. Secondary PK, PD, safety, and immunogenicity outcomes were also evaluated.RESULTS:
Of 154 participants randomized (76 CTP41; 78 US-denosumab), 151 received study drug (74 CTP41; 77 US-denosumab). Primary and secondary PK results, PD results, safety, and immunogenicity were comparable between groups. Ninety percent CIs for ratios of gLSMs were within the predefined equivalence margin for AUC0-inf (100.4-114.7), AUC0-last (99.9-114.3), and Cmax (95.2-107.3).CONCLUSIONS:
Following a single dose in healthy males, CTP41 demonstrated PK equivalence with US-denosumab. TRIAL REGISTRATION ClinicalTrials.gov NCT06037395.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Biosimilar Pharmaceuticals
/
Denosumab
Type of study:
Clinical_trials
Limits:
Adult
/
Humans
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Male
/
Middle aged
Language:
En
Journal:
Expert Opin Biol Ther
Journal subject:
BIOLOGIA
/
TERAPEUTICA
Year:
2024
Type:
Article