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

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

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

Inclusion Criteria:

1. Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;
2. Be able to complete the study as required by the study protocol;
3. Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;
4. 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:

1. Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;
2. Be able to complete the study as required by the study protocol;
3. Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;
4. 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:

1. Subjects with allergic diathesis, or history of food/drug allergy within recent 4 weeks, especially hypersensitivity to any component of investigational product or excipients;
2. Blood donation or substantial blood loss (>200 mL) within 3 months, or platelet donation within 2 weeks prior to investigational product administration;
3. Major surgery within 6 months prior to first dosing, or planned surgery during study;
4. Hereditary bleeding tendency, coagulation disorders, or history of thrombosis / hemorrhagic diseases;
5. Prior treatment with EGFR-targeted agents;
6. 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.
7. 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);
8. 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;
9. History of hepatitis B, hepatitis C, AIDS, syphilis, or clinically significant abnormality in ≥1 item of infectious disease four-panel screening;
10. 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;
11. Cigarette smoking ≥5 cigarettes/day within 3 months pre-screening;
12. 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.
13. 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;
14. Receipt of live-attenuated vaccines within 14 days prior to first dosing, or planned live-attenuated vaccination during study;
15. Intolerance to venipuncture blood collection, or history of needle-phobia or hematophobia;
16. 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.