Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04411550
Eligibility Criteria:
Inclusion Criteria:
* Healthy Chinese males
* aged ≥ 18 and ≤ 45
* body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
* LVEF≥ 55%
Exclusion Criteria:
* A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
* Use of a monoclonal antibody or any biological product within 6 months before study drug administration
* A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
* Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
* A history of blood donation within 3 months before study drug administration
* Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
* Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
* A history of drug abuse
* Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04411550
Study Brief:
Protocol Section:
NCT04411550