Evaluation of Pharmacokinetics and Safety of the Biosimilar (B01711) and Insulin Degludec/Insulin Aspart (IDegAsp, Ryzodeg) in Healthy Chinese Adults in a Randomized, Open-Label, Single-Dose, Crossover, Phase I Study.

OBJECTIVE

B01711 is a biosimilar of insulin degludec/insulin aspart (IDegAsp 70/30). This randomized, open-label, single-dose, crossover, phase I study aimed to evaluate the pharmacokinetics (PK) and safety of B01711 compared to its original product (Ryzodeg) in healthy Chinese volunteers.

METHODS

The study was conducted between April and August 2022, this study included 32 participants (22 males and 10 females) who received subcutaneous injections of both B01711 and Ryzodeg, with a ≥14-day washout period between treatments. All participants completed the study without any dropouts. Blood samples were collected at pre-defined intervals for PK analysis.

RESULTS

The primary PK parameters included the area under the curve (AUC) of insulin degludec (IDeg) from 0 to 24 hours (AUC), AUC of insulin aspart (IAsp) from 0 to the time of the last measurable value (AUC), and the peak concentration of IAsp (C). PK equivalence would be established if the 90% confidence intervals (CIs) of least squares (LS) mean ratios of log-transformed values of primary PK endpoints for B01711 compared with Ryzodeg fell within the range of 80.0% to 125.0%. Safety was monitored throughout the study. The LS-mean ratios and corresponding 90% CIs were 106.1% (101.9%, 110.5%) for AUC; 103.9% (100.2%, 107.6%) for AUC; and 110.1% (101.0%, 119.9%) for C. Two treatment-emergent adverse events (TEAEs) were reported in two subjects (6.3%) in the B01711 group, and seven TEAEs were reported in seven subjects (21.9%) in the Ryzodeg group. The most common TEAE was a decrease in hemoglobin. The adverse events (AEs) of hypokalemia and hypoglycemia were identified as treatment-related AEs (TRAEs) and all TRAEs were mild.

CONCLUSION

This study demonstrated the PK equivalence of the two drugs and confirmed that both were well-tolerated.