Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers

CTTQ

Status and phase

Completed

Phase 1

Conditions

Metastatic Breast Cancer

Metastatic Gastric Cancer

Treatments

Drug: Herceptin

Drug: Trastuzumab for injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT05765357

ZDTQ-2017-QTZDK

Details and patient eligibility

About

Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.

Enrollment

89 patients

Sex

Male

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.