CancerPhase 1NCT06980454
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
A Phase 1 study testing HLX05, EU-Erbitux® and US-Erbitux® in people with Cancer and mCRC, run by Shanghai Henlius Biotech at 2 sites in China.
Trial summary
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- What is being tested?
- HLX05, EU-Erbitux® and US-Erbitux®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 322 participants
- Where
- 2 sitesChina
- Study dates
- 4 Jun 2025to 31 Dec 2025
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects who meet all the following criteria are allowed to be enrolled:
- Males aged 18-50 years (inclusive);
- Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg;
- Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound;
- Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial;
Who cannot join
- 1. With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions; 2. Subjects with a history of seborrheic dermatitis or other types of dermatitis, rashes, etc., in the past or currently; 3. Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial; 4. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders; 5. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
Trial locations and contacts
2 sites in 1 country.
China2 sites
Affiliated Hospital of Xuzhou Medical University
Jiangsu, Xuzhou
Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu
Xuzhou, Jiangsu
About this study
Official title: A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
- Being tested
- HLX05, EU-Erbitux®, US-Erbitux®, CN-Erbitux®
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX05Drug
A single dose of 250 mg/m2 HLX05 will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.
EU-Erbitux®Drug
A single dose of 250 mg/m2 EU-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.
US-Erbitux®Drug
A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.
CN-Erbitux®Drug
A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion.
| Study group | Role | What they receive |
|---|---|---|
| HLX05 | Experimental | Not described Receives: Drug: HLX05 |
| US-sourced Erbitux® | Active comparator | Not described Receives: Drug: US-Erbitux® |
| CN-sourced Erbitux® | Active comparator | Not described Receives: Drug: CN-Erbitux® |
| EU-sourced Erbitux® | Active comparator | Not described Receives: Drug: EU-Erbitux® |
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-inf)
Measured: up to 29 days
Secondary outcomes (4)
Cmax
Maximum serum concentration
Measured: up to 29 days
Tmax
Time to reach maximum serum concentration
Measured: up to 29 days
CL
Total clearance
Measured: up to 29 days
λz
Apparent terminal elimination rate constant
Measured: up to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start4 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- 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
- 322 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980454
- Sponsor's protocol ID
- HLX05-HV01
- Status last verified
- Jul 2025
- First submitted
- 29 Apr 2025
- Last updated
- 8 Jul 2025
- 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 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
- ClinicalTrials.gov ID
- NCT06980454
- Acronym / sponsor ID
- HLX05-HV01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 322 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 4 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 May 2025 (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.
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| HLX05 | Experimental | Drug: HLX05 |
| US-sourced Erbitux® | Active comparator | Drug: US-Erbitux® |
| CN-sourced Erbitux® | Active comparator | Drug: CN-Erbitux® |
| EU-sourced Erbitux® | Active comparator | Drug: EU-Erbitux® |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects who meet all the following criteria are allowed to be enrolled:
Key exclusion criteria (1 listed)
- 1. With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions; 2. Subjects with a history of seborrheic dermatitis or other types of dermatitis, rashes, etc., in the past or currently; 3. Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial; 4. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders; 5. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
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 |
|---|---|---|
| HLX05A single dose of 250 mg/m2 HLX05 will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. | Drug | HLX05 |
| EU-Erbitux®A single dose of 250 mg/m2 EU-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. | Drug | EU-sourced Erbitux® |
| US-Erbitux®A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. | Drug | US-sourced Erbitux® |
| CN-Erbitux®A single dose of 250 mg/m2 US-Erbitux® injection will be given by intravenous drip over 2 h (± 10 min). Antihistamines (e.g., diphenhydramine 20 mg or promethazine 25 mg by intramuscular injection within 30 min prior to dosing) and corticosteroids (e.g., dexamethasone 5 mg by intravenous bolus within 30 min prior to dosing) will be given prior to infusion. | Drug | CN-sourced Erbitux® |
Primary outcome
Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: up to 29 days
4 secondary outcomes
Cmax
Time frame: up to 29 days
Tmax
Time frame: up to 29 days
CL
Time frame: up to 29 days
λz
Time frame: up to 29 days
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 8 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HLX05, EU-Erbitux® and US-Erbitux® in people with Cancer and mCRC, run by Shanghai Henlius Biotech at 2 sites 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 5 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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-inf) (time frame: up to 29 days). 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 8 Jul 2025.