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

Primary Purpose

Metastatic Breast Cancer, Metastatic Gastric Cancer

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Trastuzumab for injection
Herceptin
Sponsored by
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts 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.

Sites / Locations

  • Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Trastuzumab for injection

Herceptin

Arm Description

4mg/kg, Single dose for intravenous infusion

4mg/kg, Single dose for intravenous infusion

Outcomes

Primary Outcome Measures

Area under drug concentration - time curve (AUC0-t)
Area under the curve from time zero to the lowest detectable blood drug concentration

Secondary Outcome Measures

Area under drug concentration - time curve (AUC0-∞)
The area under the curve extrapolating from time zero to infinity
Peak concentration (Cmax)
Peak maximum plasma drug concentration
Time to reach maximum plasma (Tmax)
Time to reach maximum plasma concentration after dosing
Clearance (CL)
Percentage of the body that eliminates organ-scavenging drugs
half-life (T1/2)
The time it takes for serum drug concentrations to drop by half
Apparent volume of distribution (Vd/F)
Apparent volume of distribution after administration

Full Information

First Posted
March 1, 2023
Last Updated
March 1, 2023
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05765357
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
July 16, 2017 (Actual)
Primary Completion Date
October 27, 2017 (Actual)
Study Completion Date
October 27, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Metastatic Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trastuzumab for injection
Arm Type
Experimental
Arm Description
4mg/kg, Single dose for intravenous infusion
Arm Title
Herceptin
Arm Type
Active Comparator
Arm Description
4mg/kg, Single dose for intravenous infusion
Intervention Type
Drug
Intervention Name(s)
Trastuzumab for injection
Intervention Description
Trastuzumab for injection manufactured by Chia Tai Tianqing. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
Intervention Type
Drug
Intervention Name(s)
Herceptin
Intervention Description
Herceptin is the brand name of Trastuzumab for injection manufactured by Roche. Trastuzumab is a humanized IGG1-class monoclonal antibody produced by CHO cells. Its mechanism of action is to prevent the attachment of human epidermal growth factor to Her2 by attaching itself to Her2, thus blocking the growth of cancer cells. In addition, Trastuzumab can also stimulate the body's own immune cells to destroy cancer cells.
Primary Outcome Measure Information:
Title
Area under drug concentration - time curve (AUC0-t)
Description
Area under the curve from time zero to the lowest detectable blood drug concentration
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Secondary Outcome Measure Information:
Title
Area under drug concentration - time curve (AUC0-∞)
Description
The area under the curve extrapolating from time zero to infinity
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Title
Peak concentration (Cmax)
Description
Peak maximum plasma drug concentration
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Title
Time to reach maximum plasma (Tmax)
Description
Time to reach maximum plasma concentration after dosing
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Title
Clearance (CL)
Description
Percentage of the body that eliminates organ-scavenging drugs
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Title
half-life (T1/2)
Description
The time it takes for serum drug concentrations to drop by half
Time Frame
Within 30 minutes before administration to 1344 hours after administration
Title
Apparent volume of distribution (Vd/F)
Description
Apparent volume of distribution after administration
Time Frame
Within 30 minutes before administration to 1344 hours after administration

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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