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

NCT07246291 | Recruiting Phase 1

• 1 other identifier: CMAB009-C-102
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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

Keywords

phrase 1

Outcome Measures

Primary Outcomes (1)

• AUC0-∞

  Area under the concentration time curve extrapolated to infinity

  From enrollment to the end of treatment at 28 days

Secondary Outcomes (9)

• AUC0-t

  From enrollment to the end of treatment at 28 days

• Cmax

  From enrollment to the end of treatment at 28 days

• Tmax

  From enrollment to the end of treatment at 28 days

• t1/2

  From enrollment to the end of treatment at 28 days

• λz

  From enrollment to the end of treatment at 28 days

Study Arms (2)

New technology Enlituo

EXPERIMENTAL

treated with new technology Enlituo through single intravenous drip

Biological: New technology Enlituo

Approved technology Enlituo

ACTIVE COMPARATOR

treated with Approved technology Enlituo through single intravenous drip

Biological: Approved technology Enlituo

Interventions

New technology Enlituo BIOLOGICAL

250 mg/m\^2, single intravenous drip

New technology Enlituo

Approved technology Enlituo BIOLOGICAL

250 mg/m\^2, single intravenous drip

Approved technology Enlituo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Taizhou Mabtech Pharmaceutical Co.,Ltd: lead

Study Sites (1)

Shanghai Xuhui Central Hospital

Shanghai, China

RECRUITING

Study Officials

• Jingying Jia, PhD

  Shanghai Xuhui Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingying Jia, PhD

CONTACT

+86 21 5403 0254; jyjia@shxh-centerlab.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: November 11, 2025
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)