A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects (BT-HC034S-101)

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

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers; Pharmacokinetics; Bioequivalence; Cetuximab
• Intervention / Treatment: Drug: HC034S; Drug: Erbitux (Cetuximab)

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaoai He; Phone Number: +86-1500-897-1099; Email: 15008971099@126.com

Study Locations

• China
  • Hainan
    • Haikou, Hainan, China, 570208
      • Recruiting
      • Haikou People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HC034S	Drug: HC034S; 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.
Active Comparator: China-sourced Erbitux®	Drug: Erbitux (Cetuximab); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Apparent volume of distribution (Vd)	Up to Day 29
Apparent terminal elimination rate constant (λz)	Up to Day 29
Percentage of the area-under-the-curve extrapolated to infinity (AUC_%Extrap)	Up to Day 29
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following study drug administration, including electrocardiograms (ECG), laboratory test parameters, physical examinations, and vital signs.	Up to Day 29
Positive incidence, titer and duration of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)	Up to Day 29

Collaborators and Investigators

• Sponsor: HC Biopharma Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Cetuximab
• Other Study ID Numbers: HC034S-101; BT-HC034S-101 (Other Identifier: Shanghai Hongcheng Pharmaceutical Co., Ltd.)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No