CetuximabPhase 1BT-HC034S-101NCT07813468
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
A Phase 1 study testing HC034S and Erbitux (Cetuximab) in people with Cetuximab and Bioequivalence, run by HC Biopharma Inc. at 1 site in China.
Trial summary
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects Read more about this study
- Who is it for?
- Ages 18 to 46 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cetuximab, Bioequivalence, Healthy Volunteers
- What is being tested?
- HC034S and Erbitux (Cetuximab)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2026to 30 Jun 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 46 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Haikou People's Hospital
Haikou, Hainan, 570208
About this study
Official title: 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
- Conditions
- Cetuximab, Bioequivalence, Healthy Volunteers, Pharmacokinetics
- Being tested
- HC034S, Erbitux (Cetuximab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HC034SDrug
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| HC034S | Experimental | Not described Receives: Drug: HC034S |
| China-sourced Erbitux® | Active comparator | Not described Receives: Drug: Erbitux (Cetuximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)
Measured: Up to Day 29
Secondary outcomes (10)
quantifiable concentration (AUC₀-t)
Measured: Up to Day 29
Maximum serum concentration (Cmax)
Measured: Up to Day 29
Time to reach maximum serum concentration (Tmax)
Measured: Up to Day 29
Total clearance (CL)
Measured: Up to Day 29
Terminal elimination half-life (t1/2)
Measured: Up to Day 29
Apparent volume of distribution (Vd)
Measured: Up to Day 29
Apparent terminal elimination rate constant (λz)
Measured: Up to Day 29
Percentage of the area-under-the-curve extrapolated to infinity (AUC_%Extrap)
Measured: 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.
Measured: Up to Day 29
Positive incidence, titer and duration of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Measured: Up to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start5 Sep 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CetuximabStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HC Biopharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07813468
- Sponsor's protocol ID
- HC034S-101
- Other IDs
- BT-HC034S-101
- Acronym
- BT-HC034S-101
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No