Healthy Adult MalePhase 1NCT07246291
Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
A Phase 1 study testing New technology Enlituo and Approved technology Enlituo in people with Healthy Adult Male, run by Taizhou Mabtech Pharmaceutical Co.,Ltd at 1 site in China.
Trial summary
This study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male
- What is being tested?
- New technology Enlituo and Approved technology Enlituo
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2025to 14 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged ≥ 18 years and ≤ 45 years on the day of signing the informed consent form;
- At screening, body weight ≥ 50 kg and ≤ 80 kg, with a Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive of boundary values);
- Capable of understanding the study, including its purpose, research procedures, potential risks, etc., and able to communicate well with researchers and complete the study in accordance with the study requirements;
- Voluntarily sign the informed consent form.
Who cannot join
- Subjects with any abnormally clinically significant findings in comprehensive examinations (vital signs, physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, blood routine, urine routine, blood biochemistry, coagulation, etc.) as judged by the investigator;
- Subjects with a history of major diseases in the cardiovascular, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immune, or mental systems, or currently suffering from any disease in the above systems;
- Subjects with a known or suspected history of keratitis, ulcerative keratitis, conjunctivitis, blepharitis, or severe dry eye;
- Subjects with hereditary bleeding tendency, coagulation dysfunction, or a history of thrombotic or hemorrhagic diseases;
- Subjects with active infections requiring systemic treatment;
- Subjects positive for any of HBV surface antigen, HCV antibody, HIV antibody, or Treponema pallidum antibody;
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- Subjects with a history of malignant tumors within the past 5 years, except for completely resected in-situ cutaneous basal cell carcinoma or squamous cell carcinoma;
- Subjects who have undergone surgical operations within 4 weeks before screening, or plan to undergo surgery during the trial period;
- Subjects who have used any prescription drugs, over-the-counter drugs, traditional Chinese medicines, proprietary Chinese medicines, health supplements, etc., within 4 weeks before screening, or whose use of the above substances has not exceeded 5 half-lives (whichever is longer);
- Subjects who have used any biological products or received any vaccines within 12 weeks before screening, or plan to receive any vaccines during the study period;
- Subjects currently enrolled in other clinical studies of drugs or medical devices, or whose time since the end of the last enrolled clinical study is less than 12 weeks, or whose time since the last trial drug administration has not exceeded 5 half-lives (whichever is longer);
- Subjects positive for anti-drug antibodies against anti-epidermal growth factor receptor antibodies;
- Subjects with substance abuse, or who have used soft drugs within 3 months before screening or hard drugs within 1 year before screening; or who consume excessive tea, coffee, and/or caffeinated beverages daily (more than 8 cups, 1 cup = 250 mL); or who have a positive urine drug screen;
- Subjects with alcoholism, or whose weekly alcohol consumption exceeds 14 units within 3 months before screening (1 unit = 17.7 mL ethanol, i.e., 1 unit = 357 mL of beer with 5% alcohol content, 43 mL of liquor with 40% alcohol content, or 147 mL of wine with 12% alcohol content); or who have a positive alcohol breath test; and those who cannot cooperate with alcohol prohibition during the study;
- Subjects who smoked more than 10 cigarettes per day on average within 6 months before screening;
- Subjects who engaged in strenuous activities within 72 hours before drug administration, or cannot avoid strenuous activities during the study; or have other physiological or pathological conditions that may affect the absorption, distribution, metabolism, or excretion of the study drug;
- Subjects who have donated blood (including component blood) or lost more than 400 mL of blood, or received blood transfusions within 3 months before screening; or donated blood (including component blood) or lost more than 200 mL of blood within 1 month before screening;
- Subjects with a known history of allergy to the active ingredient or any excipient of the study drug, or to other biological products; or with a history of atopic allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.); or with allergic diathesis;
- Subjects who cannot tolerate venipuncture or have a history of fainting due to needle or blood;
- Subjects with special dietary requirements who cannot accept the diet provided by the clinical trial center;
- Subjects who cannot take effective contraceptive measures or plan to donate sperm within 3 months after the administration of the study drug;
- Other conditions deemed by the investigator to make the subject unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-Blind, Parallel-Controlled, Single-Dose Pharmacokinetic, Safety, and Immunogenicity Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
This study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers.
- Conditions
- Healthy Adult Male
- Being tested
- New technology Enlituo, Approved technology Enlituo
- Keywords
- phrase 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New technology EnlituoBiological
250 mg/m^2, single intravenous drip
Approved technology EnlituoBiological
250 mg/m^2, single intravenous drip
| Study group | Role | What they receive |
|---|---|---|
| New technology Enlituo | Experimental | treated with new technology Enlituo through single intravenous drip Receives: Biological: New technology Enlituo |
| Approved technology Enlituo | Active comparator | treated with Approved technology Enlituo through single intravenous drip Receives: Biological: Approved technology Enlituo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞
Area under the concentration time curve extrapolated to infinity
Measured: From enrollment to the end of treatment at 28 days
Secondary outcomes (9)
AUC0-t
Area under the concentration time curve from time zero to the last measurable time point.
Measured: From enrollment to the end of treatment at 28 days
Cmax
Peak concentration.
Measured: From enrollment to the end of treatment at 28 days
Tmax
time to peak
Measured: From enrollment to the end of treatment at 28 days
t1/2
half-life
Measured: From enrollment to the end of treatment at 28 days
λz
Terminal Elimination Rate Constant
Measured: From enrollment to the end of treatment at 28 days
CL
clearance
Measured: From enrollment to the end of treatment at 28 days
Vd
volume of distribution
Measured: From enrollment to the end of treatment at 28 days
Immunogenicity
Anti-drug antibody positive rate
Measured: From enrollment to the end of treatment at 28 days
Adverse Event
Incidence and Severity of Adverse Events
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start11 Nov 2025
- Primary completion14 Apr 2026
- Study completion14 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult MaleStudies 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
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jingying Jia, PhD, Principal investigator, Xuhui Central Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246291
- Sponsor's protocol ID
- CMAB009-C-102
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the study result is published, email the application registration contact or the study leader to obtain it.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Parallel-Controlled, Single-Dose Pharmacokinetic, Safety, and Immunogenicity Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT07246291
- Acronym / sponsor ID
- CMAB009-C-102
- Conditions
- Healthy Adult Male
- Keywords
- phrase 1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Taizhou Mabtech Pharmaceutical Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2025 (actual)
- Primary completion
- 14 Apr 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 24 Nov 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 study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers.
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 |
|---|---|---|
| New technology Enlituo | Experimental | Biological: New technology Enlituotreated with new technology Enlituo through single intravenous drip |
| Approved technology Enlituo | Active comparator | Biological: Approved technology Enlituotreated with Approved technology Enlituo through single intravenous drip |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males aged ≥ 18 years and ≤ 45 years on the day of signing the informed consent form;
- At screening, body weight ≥ 50 kg and ≤ 80 kg, with a Body Mass Index (BMI) between 19.0 and 26.0 kg/m² (inclusive of boundary values);
- Capable of understanding the study, including its purpose, research procedures, potential risks, etc., and able to communicate well with researchers and complete the study in accordance with the study requirements;
- Voluntarily sign the informed consent form.
Key exclusion criteria (22 listed)
- Subjects with any abnormally clinically significant findings in comprehensive examinations (vital signs, physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, blood routine, urine routine, blood biochemistry, coagulation, etc.) as judged by the investigator;
- Subjects with a history of major diseases in the cardiovascular, endocrine, nervous, digestive, respiratory, genitourinary, hematological, immune, or mental systems, or currently suffering from any disease in the above systems;
- Subjects with a known or suspected history of keratitis, ulcerative keratitis, conjunctivitis, blepharitis, or severe dry eye;
- Subjects with hereditary bleeding tendency, coagulation dysfunction, or a history of thrombotic or hemorrhagic diseases;
- Subjects with active infections requiring systemic treatment;
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 |
|---|---|---|
| New technology Enlituo250 mg/m^2, single intravenous drip | Biological | New technology Enlituo |
| Approved technology Enlituo250 mg/m^2, single intravenous drip | Biological | Approved technology Enlituo |
Primary outcome
AUC0-∞
Time frame: From enrollment to the end of treatment at 28 days
Area under the concentration time curve extrapolated to infinity
9 secondary outcomes
AUC0-t
Time frame: From enrollment to the end of treatment at 28 days
Cmax
Time frame: From enrollment to the end of treatment at 28 days
Tmax
Time frame: From enrollment to the end of treatment at 28 days
t1/2
Time frame: From enrollment to the end of treatment at 28 days
λz
Time frame: From enrollment to the end of treatment at 28 days
CL
Time frame: From enrollment to the end of treatment at 28 days
Vd
Time frame: From enrollment to the end of treatment at 28 days
Immunogenicity
Time frame: From enrollment to the end of treatment at 28 days
Adverse Event
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: Yes. After the study result is published, email the application registration contact or the study leader to obtain it.
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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.
Jingying Jia, PhD principal investigator
Xuhui Central Hospital, Shanghai
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 New technology Enlituo and Approved technology Enlituo in people with Healthy Adult Male, run by Taizhou Mabtech Pharmaceutical Co.,Ltd 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 22 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC0-∞ (time frame: From enrollment to the end of treatment at 28 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 30 Sep 2026.