scholarly journals Randomized, Open‐Label, Single‐Dose, Parallel‐Group Pharmacokinetic Study of PF‐06410293 (adalimumab‐afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects

2021 ◽  
Author(s):  
Donna S. Cox ◽  
Daniel F. Alvarez ◽  
Amy E. Bock ◽  
Carol L. Cronenberger
Keyword(s):  
Single Dose ◽  
Pharmacokinetic Study ◽  
Healthy Subjects ◽  
Open Label ◽  
Prefilled Syringe ◽  
Parallel Group

scholarly journals P568 An open-label, multicenter, phase ib, pharmacokinetic (pk) and safety study of a fimh blocker, Sibofimloc (TAK-018/EB8018), in patients with Crohn’s disease (CD)

2020 ◽  
Vol 14 (Supplement_1) ◽  
pp. S479-S480 ◽  
Author(s):  
W Reinisch ◽  
X Hébuterne ◽  
A Buisson ◽  
S Schreiber ◽  
P Desreumaux ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Development Program ◽  
Small Subset ◽  
Open Label ◽  
Faecal Calprotectin ◽  
Open Label Study ◽  
E Coli ◽  
Clinical Development Program ◽  
Phase 2 Trial

Abstract Background Sibofimloc (EB8018/TAK-018) is a gut-restricted orally administered, first-in-class, FimH blocker that targets FimH, a TLR4 receptor, expressed on E. coli and other Enterobacteriaceae in patients with CD. In a previous study, sibofimloc up to 1500 mg twice daily was well tolerated when administered to healthy subjects over a 14-day period. PK results indicated that sibofimloc was detectable in plasma at a very low level. The current study investigated the PK, safety, and pharmacodynamic effects of sibofimloc following 13 days of 1500 mg twice daily oral administration in patients with CD. Objectives of this study were to determine the PK (primary) and safety profiles, effects on inflammatory biomarkers, gut microbiome and on stool frequency and pain score. Methods We conducted a multicenter open-label study to enrol 8 adult patients with active CD (faecal calprotectin (FCP) ≥150 µg/g and/or ulcers at colonoscopy). Pregnant women were excluded. This study was divided into two parts. 1)Two patients received a single dose of 3000 mg sibofimloc followed, after a wash-out period, by a 13 day-period with1500 mg twice daily. 2)After review of data from these two patients, the 6 remaining patients received 1500 mg sibofimloc twice daily for a 13 day period. Results Cmax values for the 2 initial patients (after single dose 3000 mg sibofimloc) were 51.3 and 348 ng/ml respectively and allowed part 2 of the study. The main safety and PK data of an interim analysis after the first 4 patients had been treated with sibofimloc 1500 mg twice daily are presented in the table. In a previous study in 7 healthy subjects, after 14 days sibofimloc 1500 mg twice daily, median Cmax[min-max] at Day14 was 49[19.2–86.6]ng/ml. Conclusion These preliminary data confirmed that sibofimloc was well tolerated. In the small subset of patients analyzed, there was a slightly higher plasma exposure and interpatient variability compared with what has been seen earlier in healthy subjects. The safety and PK data allowed the continuation of the clinical development program with the initiation of a phase 2 trial for postoperative maintenance in patients with CD.

scholarly journals A randomised, single-blind, single-dose, three-arm, parallel-group study in healthy subjects to demonstrate pharmacokinetic equivalence of ABP 501 and adalimumab

2016 ◽  
Vol 76 (3) ◽  
pp. 526-533 ◽  
Author(s):  
Primal Kaur ◽  
Vincent Chow ◽  
Nan Zhang ◽  
Michael Moxness ◽  
Arunan Kaliyaperumal ◽  
...  
Keyword(s):  
Single Dose ◽  
Healthy Subjects ◽  
Study Groups ◽  
Time Curve ◽  
End Points ◽  
Parallel Group Study ◽  
Parallel Group ◽  
The Usa ◽  
Abp 501 ◽  
Single Blind

ObjectiveTo demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501.MethodsRandomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (Cmax). Secondary end points included safety and immunogenicity.ResultsAUCinf and Cmax were similar across the three groups. Geometrical mean ratio (GMR) of AUCinf was 1.11 between ABP 501 and adalimumab (USA), and 1.04 between ABP 501 and adalimumab (EU). GMR of Cmax was 1.04 between ABP 501 and adalimumab (USA) and 0.96 between ABP 501 and adalimumab (EU). The 90% CIs for the GMRs of AUCinf and Cmax were within the prespecified standard PK equivalence criteria of 0.80 to 1.25. Treatment-related adverse events were mild to moderate and were reported for 35.8%, 24.6% and 41.8% of subjects in the ABP 501, adalimumab (USA) and adalimumab (EU) groups; incidence of antidrug antibodies (ADAbs) was similar among the study groups.ConclusionsResults of this study demonstrated PK similarity of ABP 501 with adalimumab (USA) and adalimumab (EU) after a single 40-mg subcutaneous injection. No new safety signals with ABP 501 were identified. The safety and tolerability of ABP 501 was similar to the reference products, and similar ADAb rates were observed across the three groups.Trial registration numberEudraCT number 2012-000785-37; Results.

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