Clinical trial NCT05765357: Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Official title: Phase I Clinical Study of Randomized, Double-blind, Single-dose, Parallel Comparison of Trastuzumab for Injection and Herceptin® in Healthy Male Volunteers on Pharmacokinetics and Safety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Breast Cancer
Metastatic Gastric Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-13
Enrollment: 89
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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®.


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.

Primary outcomes:
measure: Area under drug concentration - time curve (AUC0-t)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
Secondary outcomes:
measure: Area under drug concentration - time curve (AUC0-∞)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
measure: Peak concentration (Cmax)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
measure: Time to reach maximum plasma (Tmax)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
measure: Clearance (CL)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
measure: half-life (T1/2)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
measure: Apparent volume of distribution (Vd/F)
timeFrame: Within 30 minutes before administration to 1344 hours after administration
Other outcomes:
Locations:
city: Changchun
country: China
facility: Affiliated Hospital of Changchun University of Traditional Chinese Medicine
state: Jilin
Study officials:
References: