Clinical trial · Interventional
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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®.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Herceptin | Drug | Trastuzumab | ALIAS |
| Trastuzumab for injection | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Trastuzumab for injection
- description
- 4mg/kg, Single dose for intravenous infusion
- interventionNames
- Drug: Trastuzumab for injection
- type
- ACTIVE_COMPARATOR
- label
- Herceptin
- description
- 4mg/kg, Single dose for intravenous infusion
- interventionNames
- Drug: Herceptin
Primary outcomes (1)
- measure
- Area under drug concentration - time curve (AUC0-t)
- timeFrame
- Within 30 minutes before administration to 1344 hours after administration
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available