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
- Are there results?
- Not yet: the study is under way
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;
Show all 20Show fewer
- 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-Blind, Positive-Controlled, Parallel-Group Pharmacokinetic Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT07813468
- Acronym / sponsor ID
- BT-HC034S-101 / HC034S-101
- Conditions
- Cetuximab, Bioequivalence, Healthy Volunteers, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- HC Biopharma Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HC034S | Experimental | Drug: HC034S |
| China-sourced Erbitux® | Active comparator | Drug: Erbitux (Cetuximab) |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HC034SSingle 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. | Drug | HC034S |
| 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. | Drug | China-sourced Erbitux® |
Primary outcome
Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)
Time frame: Up to Day 29
10 secondary outcomes
quantifiable concentration (AUC₀-t)
Time frame: Up to Day 29
Maximum serum concentration (Cmax)
Time frame: Up to Day 29
Time to reach maximum serum concentration (Tmax)
Time frame: Up to Day 29
Total clearance (CL)
Time frame: Up to Day 29
Terminal elimination half-life (t1/2)
Time frame: Up to Day 29
Apparent volume of distribution (Vd)
Time frame: Up to Day 29
Apparent terminal elimination rate constant (λz)
Time frame: Up to Day 29
Percentage of the area-under-the-curve extrapolated to infinity (AUC_%Extrap)
Time frame: 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.
Time frame: Up to Day 29
Positive incidence, titer and duration of anti-drug antibodies (ADA) and neutralizing antibodies (NAb)
Time frame: Up to Day 29
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Related trials for Cetuximab
RecruitingPhase 3
Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Advanced Head and Neck Cancer Who Cannot Receive Cisplatin
Locally Advanced Hypopharyngeal Squamous Cell Carcinoma, Locally Advanced Laryngeal Squamous Cell Carcinoma
RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
Colorectal Cancer (CRC)
RecruitingPhase 3
Testing the Addition of Anti-Cancer Drug, Cetuximab, to Standard of Care Treatment (Pembrolizumab) for Returning or Spreading Head and Neck Cancer After Previous Treatment
Metastatic Head and Neck Squamous Cell Carcinoma, Metastatic Hypopharyngeal Squamous Cell Carcinoma
RecruitingPhase 1/2
JAB-23E73 in Adult Participants With Advanced Solid Tumors With KRAS Alteration
Advanced Solid Tumors
Active, not recruitingPhase 1/2
Rollover Study for Participants Who Have Been Treated With and Are Continuing to Benefit From Opnurasib as a Single Agent or in Combination With Other Study Treatments
Locally Advanced or Metastatic KRAS G12C-mutated Non-small Cell Lung Cancer, Advanced Solid Tumors Harboring the KRAS G12C Mutation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoai He (+86-1500-897-1099, 15008971099@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞) (time frame: Up to Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.