Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers

NCT ID: NCT07246291

Last Updated: 2025-11-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2026-02-03

Brief 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.

Conditions

Healthy Adult Male

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

New technology Enlituo

treated with new technology Enlituo through single intravenous drip

Group Type: EXPERIMENTAL

New technology Enlituo

Intervention Type: BIOLOGICAL

250 mg/m\^2, single intravenous drip

Approved technology Enlituo

treated with Approved technology Enlituo through single intravenous drip

Group Type: ACTIVE_COMPARATOR

Approved technology Enlituo

Intervention Type: BIOLOGICAL

250 mg/m\^2, single intravenous drip

Interventions

New technology Enlituo

250 mg/m\^2, single intravenous drip

Intervention Type: BIOLOGICAL

Approved technology Enlituo

250 mg/m\^2, single intravenous drip

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taizhou Mabtech Pharmaceutical Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jingying Jia, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Xuhui Central Hospital

Locations

Shanghai Xuhui Central Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jingying Jia, PhD

Role: CONTACT

jyjia@shxh-centerlab.com

+86 21 5403 0254

Facility Contacts

Jingying Jia, PhD

Role: primary

jyjia@shxh-centerlab.com

+86 21 5403 0254

Role: backup

jyjia@shxh-centerlab.com

Other Identifiers

CMAB009-C-102

Identifier Type: -

Identifier Source: org_study_id