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Introduction <p>This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux<sup>®</sup>) in healthy Chinese male subjects.</p> Methods <p>We conducted a randomized, single-dose, double-blind, parallel-controlled phase&#xa0;I study in which 82&#xa0;healthy subjects were randomized equally into the A140 group and the cetuximab group. Both the test and comparator drug were administered as a single intravenous (IV) dose of 250&#xa0;mg/m<sup>2</sup>. Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of the A140 to cetuximab for area under the concentration–time curve from time zero to the last measurable concentration (AUC<sub>0–<i>t</i></sub>) were within the predefined bioequivalence range of 80–125%.</p> Results <p>The results showed that the 90%&#xa0;CI of the GMR for PK parameters (AUC<sub>0–<i>t</i></sub>, AUC<sub>0–∞</sub>, <i>C</i><sub>max</sub>) between the A140 and cetuximab groups were all within the predefined equivalent interval of 80–125%. Furthermore, the types of treatment-related adverse events were similar between the two groups, with an incidence of 100%. However, approximately 80% of these events belonged to Common Terminology Criteria for Adverse Events (CTCAE) grade&#xa0;1 or 2. Anti-drug antibody (ADA) profiles were comparable between the A140 and the cetuximab group.</p> Conclusion <p>A140 demonstrated similar PK to cetuximab and comparable safety and immunogenicity in healthy Chinese male subjects.</p> Trial Registration <p>CTR20182229 (<a href="https://www.chinadrugtrials.org.cn/">https://www.chinadrugtrials.org.cn/</a>).</p>

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A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux®) in Healthy Chinese Male Subjects

  • 期刊论文

  • 发表日期：

    2025年4月15日

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  • Jia Xu,
  • Junyou Ge,
  • Yaling Li,
  • Shulin Liu,
  • Sicong Li,
  • Jing Si,
  • Juncheng Liu,
  • Xiaoxue Zhu,
  • Yanhua Ding

摘要

Introduction

This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux®) in healthy Chinese male subjects.

Methods

We conducted a randomized, single-dose, double-blind, parallel-controlled phase I study in which 82 healthy subjects were randomized equally into the A140 group and the cetuximab group. Both the test and comparator drug were administered as a single intravenous (IV) dose of 250 mg/m2. Blood samples were collected as per a designated schedule to evaluate PKs and immunogenicity. Safety was assessed throughout the study. PK similarity was concluded if the 90% confidence intervals (CIs) for the geometric mean ratios (GMRs) of the A140 to cetuximab for area under the concentration–time curve from time zero to the last measurable concentration (AUC0–t) were within the predefined bioequivalence range of 80–125%.

Results

The results showed that the 90% CI of the GMR for PK parameters (AUC0–t, AUC0–∞, Cmax) between the A140 and cetuximab groups were all within the predefined equivalent interval of 80–125%. Furthermore, the types of treatment-related adverse events were similar between the two groups, with an incidence of 100%. However, approximately 80% of these events belonged to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or 2. Anti-drug antibody (ADA) profiles were comparable between the A140 and the cetuximab group.

Conclusion

A140 demonstrated similar PK to cetuximab and comparable safety and immunogenicity in healthy Chinese male subjects.

Trial Registration

CTR20182229 (https://www.chinadrugtrials.org.cn/).