Healthy male volunteers biosimilar pharmacokinetic safety trastuzumab
Conditions
Interventions
A single dose of WT-1 Trastuzumab of 6 mg per kg body weight IV infusion over 90 minutes.,A single dose of Herceptin of 6 mg per kg body weight IV infusion over 90 minutes.
Experimental Biological/Vaccine,Active Comparator Biological/Vaccine
WT-1 Trastuzumab,Herceptin - the reference product
Sponsors
Chulabhorn Foundation by Chulabhorn Research Institute
Eligibility
Sex/Gender
Male
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. Is willing to sign a written informed consent document; 2. Is a healthy male subject aged 20 to 50 years: Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination including blood pressure and pulse rate measurement, 12-lead electrocardiogram (ECG), and routine clinical laboratory tests; 3. Has Body Mass Index (BMI) between 18.5 to 25.0 kg/m2 and a total body weight not less than 50 kg; 4. Has left ventricular ejection fraction (LVEF) within the normal range as measured by echocardiogram within 4 weeks prior to randomization (LVEF not less than 60%); 5. Agrees to use reliable contraceptive methods for both the subjects and their spouses/partners during the study period and for 6 months after the study drug infusion; 6. Must not be currently participating in any other clinical study.
Exclusion criteria
Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Has evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic disease, or clinical findings at screening, based on interview, medical history and physical examination. However, untreated, asymptomatic seasonal allergies at the time of dosing is not excluded; 2. Has Infection requiring systemic anti-infective treatment within 14 days of study randomization; 3. Has clinically significant abnormalities in laboratory test results under investigator judgement; 4. Has previous exposure to a monoclonal antibody or current use of other biologics; 5. Has prior exposure to trastuzumab or related compounds; 6. Has history of allergic or anaphylactic reaction to any of the excipients of this investigational product, Herceptin or any other drug; 7. Has history of severe dyspnea at rest requiring supplementary oxygen therapy; 8. Has history of surgery or major trauma within 12 weeks of screening, or surgery planned during the study; 9. Has history of alcohol or drug abuse in the 12 months prior to screening; defined by more than 15 standard drinks per week. One standard drink contains 10 grams of alcohol; 330 mL of beer, 30 mL of spirit or 100 mL of wine. 10. Whose spouses/partners plan to become pregnant; 11. Use of prescription or non-prescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication (unless in the opinion of the Investigator, the medication did not interfere with the study procedures or compromise subject safety). Herbal supplements must be discontinued 14 days prior to the first dose of study medication; 12. Has other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome Pre-dose, 0.5, 1, 1.5, 3, 6, 8, 12, 24, 36, and 48 hours after infusion start, and at Day 4, 6, 9, 16, 23, and 36. Primary PK parameter (AUC 0-inf),Primary outcome From date of first dose to completion of AE follow-up (End of Study on Day 71) Proportion of participants with Adverse Events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome upto Day 36 Secondary PK parameters (Cmax, Tmax, T1/2, Vd, CL, AUC 0-last) | — |
Countries
Thailand
Contacts
Public ContactTanchanok Ratanajarusiri
Department of Medical Services, Ministry of Public Health
Outcome results
None listed