A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects

Inclusion criteria

• Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;
• Be able to complete the study as required by the study protocol;
• Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;
• Be healthy male subjects aged 18-46 years (inclusive); body weight ≥50 kg; body mass index (BMI, calculated as weight [kg]/height² [m²]) ranging from 18.0 to 28.5 kg/m² (inclusive).

Exclusion criteria

• Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;
• Be able to complete the study as required by the study protocol;
• Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;
• Be healthy male subjects aged 18-46 years (inclusive); body weight ≥50 kg; body mass index (BMI, calculated as weight [kg]/height² [m²]) ranging from 18.0 to 28.5 kg/m² (inclusive).

Exclusion criteria

• Subjects with allergic diathesis, or history of food/drug allergy within recent 4 weeks, especially hypersensitivity to any component of investigational product or excipients;
• Blood donation or substantial blood loss (>200 mL) within 3 months, or platelet donation within 2 weeks prior to investigational product administration;
• Major surgery within 6 months prior to first dosing, or planned surgery during study;
• Hereditary bleeding tendency, coagulation disorders, or history of thrombosis / hemorrhagic diseases;
• Prior treatment with EGFR-targeted agents;
• Use of prescription / over-the-counter drugs or nutritional supplements within 5 half-lives of the product OR within 2 weeks before study drug administration (whichever is longer). Discontinue traditional Chinese medicinal supplements 28 days prior to study drug administration, except for topical products with no systemic absorption.
• Clinically significant abnormalities as assessed by investigator in vital signs (SBP <90 mmHg or >140 mmHg; DBP >90 mmHg), physical examination, ECG (resting heart rate <50 or >100 beats/min), laboratory tests (blood biochemistry, CBC, urinalysis, coagulation);
• Presence of any investigator-identified clinically significant disease, including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, neoplastic, pulmonary, immune, psychiatric, cardiovascular and cerebrovascular disorders;
• History of hepatitis B, hepatitis C, AIDS, syphilis, or clinically significant abnormality in ≥1 item of infectious disease four-panel screening;
• Alcohol intake ≥14 units/week within 3 months pre-screening (1 unit = 285 mL beer, 25 mL 40%-ABV spirits, 150 mL 12%-ABV wine); alcohol-containing products consumed within 24 h prior to study drug dosing; positive alcohol breath test at screening;
• Cigarette smoking ≥5 cigarettes/day within 3 months pre-screening;
• Drug abuse history within 5 years, illicit drug use within 3 months before screening, habitual use of any medicines (including herbal medicines), or positive urine drug screen.
• Participation in any drug clinical trial with investigational product administration, or medical device trial receiving device treatment, or use of drugs of the same class within 3 months prior to screening;
• Receipt of live-attenuated vaccines within 14 days prior to first dosing, or planned live-attenuated vaccination during study;
• Intolerance to venipuncture blood collection, or history of needle-phobia or hematophobia;
• Any subject who, in investigator's judgment, may be unable to provide informed consent or follow the protocol; whose participation may bias study results or endanger subject safety; or otherwise considered unsuitable for study enrollment.