Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers (NCT07246291) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers
China86 participantsStarted 2025-11-11
Plain-language 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.
Who can participate
Age range18 Years – 45 Years
SexMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 h…
What they're measuring
1
AUC0-∞
Timeframe: From enrollment to the end of treatment at 28 days