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Bioequivalence of Two Firsekibart Subcutaneous Formulations: A Randomized, Double-Blind, Single-Dose, Parallel-Group
Yehua Xie1, Xiao Li2, Yushi Chen2
1Changchun GeneScience Pharmaceutical Co., Ltd., Shanghai, China.
Clinical Pharmacology in Drug Development
|July 20, 2026
Summary
A new firsekibart solution for injection is bioequivalent to the lyophilized powder formulation. This study in healthy Chinese males found comparable pharmacokinetic profiles and safety for both firsekibart products.
Area of Science:
- Pharmacokinetics and Drug Development
- Clinical Pharmacology
- Biopharmaceutical Sciences
Background:
- Firsekibart is an important therapeutic agent.
- Evaluating new drug formulations is crucial for improving patient convenience and therapeutic outcomes.
- A novel solution for injection formulation of firsekibart was developed.
Purpose of the Study:
- To assess the pharmacokinetic (PK) bioequivalence between a new firsekibart solution for injection (test) and the existing firsekibart lyophilized powder for solution (reference).
- To evaluate the safety and tolerability of the new firsekibart formulation compared to the reference product.
Main Methods:
- A randomized, double-blind, parallel-group study was conducted in healthy Chinese adult males.
- Participants received a single subcutaneous dose of 200 mg of either the test or reference firsekibart formulation.
- Pharmacokinetic parameters, including Cmax and AUC, were measured, and safety assessments were performed up to Day 141.
Main Results:
- Pharmacokinetic profiles were comparable between the test and reference products.
- Least-squares geometric mean ratios (90% CIs) for Cmax, AUC(0-t), and AUC(0-inf) were within the bioequivalence range (80.00%-125.00%).
- The incidence of treatment-emergent adverse events was similar between groups, with no treatment-related serious adverse events reported.
Conclusions:
- The firsekibart solution for injection is bioequivalent to the firsekibart lyophilized powder for solution in healthy Chinese males.
- The new formulation demonstrates a comparable safety profile to the reference product.
- No new safety concerns were identified with the firsekibart solution for injection.
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