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

NCT07813468 | Recruiting Phase 1

• 2 other identifiers: HC034S-101BT-HC034S-101
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cetuximab; Bioequivalence; Healthy Volunteers; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)

  Up to Day 29

Secondary Outcomes (10)

• quantifiable concentration (AUC₀-t)

  Up to Day 29

• Maximum serum concentration (Cmax)

  Up to Day 29

• Time to reach maximum serum concentration (Tmax)

  Up to Day 29

• Total clearance (CL)

  Up to Day 29

• Terminal elimination half-life (t1/2)

  Up to Day 29

Study Arms (2)

HC034S

EXPERIMENTAL

Drug: HC034S

China-sourced Erbitux®

ACTIVE COMPARATOR

Drug: Erbitux (Cetuximab)

Interventions

Erbitux (Cetuximab) DRUG

Single intravenous infusion. Study participants shall be pre-medicated with antihistamines and corticosteroids no less than 1 h before the first cetuximab injection infusion. Administer intravenously by infusion pump at 250 mg/m² (body surface area), infusion duration: 2 h ± 10 min.

China-sourced Erbitux®

HC034S DRUG

Single intravenous infusion. Study participants shall be pre-medicated with antihistamines and corticosteroids no less than 1 h before the first HC034S injection infusion. Administer intravenously by infusion pump at 250 mg/m² (body surface area), infusion duration: 2 h ± 10 min.

HC034S

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).
• 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;

Sponsors & Collaborators

• HC Biopharma Inc.: lead

Study Sites (1)

Haikou People's Hospital

Haikou, Hainan, 570208, China

RECRUITING

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Xiaoai He

CONTACT

+86-1500-897-1099; 15008971099@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Locations

CN (1)