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Objective:  Pharmacokinetic (PK) similarity between biosimilar candidate LRG201902 and European Union-sourced liraglutide reference product (Victoza ® ) was evaluated. Safety and immunogenicity were also assessed.    Methods:  This single-dose, randomized, open-label, 2-period crossover study (CTR20192342) was conducted in thirty-eight healthy adult male subjects. Volunteers were randomized 1:1 at the beginning to receive a single 0.6 mg dose of Victoza ®  or LRG201902 by subcutaneous injection during the first period. Following 8 days washout period, all subjects received the alternate formulation during the second period. Blood samples were collected up to 72 h after administration. The primary pharmacokinetic endpoints were AUC 0–t , AUC 0–∞ , and C max . Pharmacokinetic similarity was achieved if 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC0-t, AUC 0–∞ , and C max  were within the range of 80–125%. Other pharmacokinetic parameters including T max , t ½ , and λ z  were also measured. Safety profile and immunogenicity data were collected from each subject.    Results:  C max , AUC 0–t , and AUC 0–∞  were similar between the two groups. GMRs of Cmax, AUC 0–t , and AUC 0–∞  were 113.50%, 107.21%, and 106.97% between LRG201902 and Victoza ®  respectively. The 90% CIs for the GMRs of C max , AUC 0-t , and AUC 0–∞  were all within the PK equivalence criteria. Mean serum concentration-time profiles, secondary pharmacokinetic parameters (T max , t ½ , and λ z ) were comparable between groups. Treatment-related adverse events were reported by 27.8% and 23.7% subjects in the LRG201902 and Victoza ®  arms, respectively. All post-dose samples were detected negative for anti-drug antibodies.    Conclusion:  This study demonstrates pharmacokinetic similarity of LRG201902 to Victoza ®  in healthy subjects. The safety and immunogenicity profiles were similar for the two products.

A Randomized Phase 1 Pharmacokinetic Study Comparing the Potential Biosimilar LRG201902 With Liraglutide (Victoza®) in Healthy Male Subjects