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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT05765357
Eligibility Criteria:
Inclusion Criteria:
* Fully understand the purpose of the trial, and have a basic understanding of the pharmacological effects and possible adverse reactions of the drug under study; Voluntary written informed consent in accordance with the Helsinki Declaration;
* Healthy male subjects aged ≥ 18 years and ≤ 65 years;
* Body weight ≥ 50 kg ≤ 90 kg, body mass index ≥ 18 ≤ 28kg/m2;
* The system examination indicators were within the normal range, or the examination results were abnormal but the researchers judged that there was no clinical significance;
* Subjects agree to use reliable contraceptive methods for both themselves and their partners during the study period and for 6 months after the study drug infusion.
Exclusion Criteria:
* History of hypertension or abnormal blood pressure at screening/baseline measurement;
* A history of albuminuria or albuminuria as assessed by the investigator as clinically significant;
* Received any antibody or protein targeting Vascular Endothelial Cell Growth Factor (VEGF) or VEGF receptors in the previous 1 year;
* Study the use of any biological product or live virus vaccine within 3 months prior to drug infusion, or the use of any monoclonal antibody within 12 months;
* Have an inherited tendency to bleed or have coagulation dysfunction, or have a history of thrombosis or bleeding;
* History of digestive tract perforation or digestive tract fistula;
* Unhealed wound ulcers or fractures, or major surgery within 2 months prior to randomization or expected to be performed during the study period or within 2 months after study completion;
* Use of a prescription or over-the-counter drug or nutritional supplement within the 5 half-life of the drug or nutritional supplement or within 2 weeks prior to the study drug use;
* Positive virology test;
* Known allergy to trastuzumab;
* Known history of allergic diseases or allergic constitution;
* Study the history of blood donation 3 months before drug infusion;
* Received any other investigational drug therapy or participated in another interventional clinical trial within 2 months prior to screening
* A history of alcohol or drug abuse in the 12 months prior to screening;
* A history of mental illness;
* Subjects whose spouses plan to become pregnant;
* The study cannot be completed according to protocol requirements during the study period;
* Conditions considered unsuitable for inclusion by other researchers.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05765357
Study Brief:
Protocol Section:
NCT05765357