A Randomized, Double-blind, Parallel-group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of LY01008, a Candidate Bevacizumab Biosimilar, with its Reference Product Avastin® in Healthy Chinese Male Subjects

2021 ◽  
Author(s):  
Zhou Renpeng ◽  
Yang Jingjing ◽  
Liu Yueyue ◽  
Zhang Qian ◽  
Lu Chao ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Study ◽  
Reference Product ◽  
Double Blind ◽  
Parallel Group ◽  
Healthy Chinese ◽  
Male Subjects ◽  
Chinese Male

scholarly journals A Phase I, Randomized, Single-Dose Study to Evaluate the Biosimilarity of HOT-3010 to Adalimumab Among Healthy Chinese Male Subjects

2021 ◽  
Vol 12 ◽  
Author(s):  
Hong Zhang ◽  
Hong Chen ◽  
Xiaojiao Li ◽  
Min Wu ◽  
Xiaoxue Zhu ◽  
...  
Keyword(s):  
Reference Product ◽  
Parallel Study ◽  
Double Blind ◽  
Single Dose Study ◽  
Reference Drug ◽  
Treatment Groups ◽  
Dose Study ◽  
Healthy Chinese ◽  
Male Subjects ◽  
Chinese Male

Objective: This study explored the bioequivalence of a proposed biosimilar HOT-3010 vs. its reference product (adalimumab) among healthy Chinese male subjects. The study also investigated the tolerance, immunogenicity, and pharmacokinetics (PK).Methods: A randomized, double-blind, two-arm, parallel study was performed to examine the bioequivalence of HOT-3010 (40 mg) with that of adalimumab (Humira®, AbbVie) as a reference drug. The study subjects were followed up for 71 days.Results: PK properties exhibited by HOT-3010 (N = 66) and adalimumab (N = 68) groups were similar. The 90% confidence intervals of the ratios for Cmax, AUC0-t, and AUC0∞ were observed to be in the range 80–125% on comparing the two groups. For anti-drug antibodies (ADA), the number of subjects found to be positive in the HOT-3010 group and adalimumab group were 29 (43.94%) and 32 (47.06%), whereas 27 (40.91%) and 27 (39.71%) subjects were found to be positive for NAb, respectively. Treatment-related treatment-emergent adverse events (TEAEs) were recorded in 32 subjects each in both the groups, respectively.Conclusion: The PK characteristics and immunogenicity exhibited by HOT-3010 were similar to that of the reference product, adalimumab. The safety profiles were similar in both the treatment groups with mild-moderate adverse effects.

scholarly journals A Biosimilarity Study Between QX001S and Ustekinumab in Healthy Chinese Male Subjects

2021 ◽  
Vol 12 ◽  
Author(s):  
Lei Gao ◽  
Qingmei Li ◽  
Hong Zhang ◽  
Min Wu ◽  
Min Fang ◽  
...  
Keyword(s):  
Adverse Reactions ◽  
Geometric Mean ◽  
Area Under The Curve ◽  
Double Blind ◽  
Upper Respiratory Infection ◽  
Subject Variability ◽  
Healthy Chinese ◽  
Male Subjects ◽  
Chinese Male ◽  
Quantifiable Concentration

Objective: To evaluate the tolerance, variability, and pharmacokinetics (PK) of QX001S, a biosimilar for ustekinumab, in healthy Chinese men.Methods: One hundred and seventy-eight healthy men were recruited in this randomized, double-blind, single-dose, two-arm, parallel study, and received 45 mg of QX001S or ustekinumab in a single subcutaneous injection. PK, immunogenicity, and tolerance were evaluated in all participants for a period of 113°days.Results: The similarity between the two drugs was determined by comparing the baseline characteristics for each drug. The PK parameters were similar in the two groups: QX001S (n = 89) and ustekinumab (n = 88). The 90% confidence intervals (CIs) for the geometric mean ratio (GMR) of QX001S to the reference (ustekinumab) for the maximum observable serum concentration (Cmax), area under the curve (AUC) from zero to the final quantifiable concentration (AUC0–t), and AUC from zero to infinity (AUC0–∞) were 100.90–118.68%, 98.71–115.26%, and 98.49–115.81%, respectively, which were within the predefined bioequivalence limit of 80.00–125.00%. High inter-subject variability (ranging from 32.0 to 33.5%) was observed. A total of 17 participants (19.1%) in the QX001S group and 36 (40.9%) in the ustekinumab group developed anti-drug antibodies (ADA) after administration. Nevertheless, the ADA did not affect the outcomes of the bioequivalence tests. Adverse reactions were recorded in 38 individuals injected with QX001S and 37 injected with ustekinumab. The most common adverse reactions were upper respiratory infection and elevated alanine aminotransferase.Conclusions: Our study ratified pharmacokinetic biosimilarity between QX001 S and ustekinumab, with high variability between subjects.

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