Safety, pharmacokinetics, and bioequivalence of vunakizumab injection, a specific dermatitis drug, in healthy Chinese volunteers: an open-label, randomized, two-stage, two-sequence cross-over study.

OBJECTIVES

Vunakizumab (SHR-1314) is a novel IL-17A monoclonal antibody that has demonstrated great efficacy and safety in treating moderate-to-severe plaque psoriasis. This study aimed to evaluate the pharmacokinetics and safety of vunakizumab to healthy subjects following subcutaneous administration via a single 2 mL automatic injection (AI) pen compared to two 1 mL AI pen injections.

METHODS

This study was a randomized, open-label, two-stage, two-sequence crossover design. Participants were randomly assigned to either the 2 mL × 1 AI injection group or the 1 mL × 2 AI injection group. Injection site pain was assessed using a visual analog scale (VAS) at predefined time points. Participants' preferred dosing method was evaluated 2 weeks post-Day 43. The relative bioavailability was determined based on Cmax and AUC0-28d.

RESULTS

No significant differences were observed between the two groups in VAS scores, injection site reactions, or the incidence of treatment-related adverse events. The geometric mean ratios for Cmax and AUC0-28d were 109% and 107%, respectively.

CONCLUSION

Both injection devices were well-tolerated in terms of safety. Participants preferred a single 2 mL subcutaneous injection over two 1 mL subcutaneous injections.Clinical Trial Registration www.clinicaltrials.gov, identifier: NCT06182384.