A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)

Launched by INCEPTA PHARMACEUTICALS LTD · Mar 19, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Trastuzumab, which is used for certain types of breast cancer that have a specific marker known as HER2. The study aims to compare a version of Trastuzumab made by Incepta Pharmaceuticals with the original version from Roche. Researchers want to understand how the body absorbs the drug, how well it works, and if it is safe for patients.

To participate in this study, you need to be a healthy adult male between the ages of 18 and 55, weigh at least 50 kg, and have a body mass index (BMI) between 18.5 and 30.0. You should not smoke or have any serious health problems, especially related to the heart or other major organs. Participants will be expected to follow the study guidelines and attend follow-up appointments. It’s important to note that this trial is currently not recruiting new participants, so if you or someone you know is interested, you may need to wait until the study is open again.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult male participant, age 18 to 55 years old
• • BMI 18.5 to 30.0 weight in kg/height in meter2; BMI value should be rounded off to one significant digit after decimal point. Volunteer having body weight at least 50 Kg.
• • Non-smokers and non-tobacco user (i.e. having no past history of smoking and tobacco consuming for at least one year prior to study)
• • Able to understand procedure, agree to participate and willing to give informed consent.
• • Willing and able to comply with the study procedures, restrictions and requirements as judged and confirmed by the principal investigator
• • Male subjects, if married, must agree that they and their spouse will use adequate contraception or be of non-childbearing potential.
• Exclusion Criteria:
• • Have significant diseases or clinically significant abnormal findings during screening \[medical history, physical examination, vital signs, laboratory evaluations, ECG, Echocardiography (LVEF less than 55%)\]. Any disease or condition like diabetes, psychosis or others which might compromise the haemopoietic, gastrointestinal, renal, hepatic, cardiovascular, ophthalmic, pulmonary, metabolic, endocrine, immunological, respiratory, central nervous system or any other body system.
• • History of and/or current cardiac disease
• • Neutrophil count less than the lower limit of normal range during screening.
• • A positive hepatitis screen (includes subtypes B \& C).
• • Use of hematopoietic growth factors, monoclonal antibodies or immunoglobulins within last 6 months prior to the study medication administration.
• • History of any cancer, including carcinoma in situ
• • Volunteer with history of angina, dyspnea, orthopnea, congestive heart failure or myocardial infarction
• • Have received live vaccine(s) within 30 days prior to Screening or who will require a vaccine(s) between Screening and the End of Study visit.
• • History or evidence of drug abuse or of alcoholism or of moderate alcohol use.