A study comparing the study drug BP02 and Herceptin® in healthy men.

Phase 1

Not yet recruiting

• Conditions: HER2 Positive Tumours; Cancer - Any cancer

• Registration Number: ACTRN12621000573853
• Lead Sponsor: CuraTeQ Biologics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-17
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: Male
• Target Recruitment: 111

Inclusion Criteria

1.Signed and dated written informed consent prior to any study-specific procedures, ability to understand, and willingness to comply with the study procedures, restrictions, and requirements as judged and confirmed by the Investigator.

2.Healthy adult male subjects, 18 to 65 years (both inclusive) of age at the time of signing informed consent.

3.Having body mass index (BMI) between 18 to 30 kg/m2 and body weight between 50 to 100 kg (all inclusive).

4.Subjects with no clinically relevant abnormalities detected during baseline history, physical examination and vital signs (blood pressure, pulse rate, body temperature, including respiratory rate) as judged by the Investigator.

5.Subjects who are considered healthy as determined by clinically acceptable findings of hematology, biochemistry, coagulation tests, urinalysis, 12-lead ECG, and echocardiogram.

6.Subjects with normal thyroid function (subjects on thyroid supplementation therapy will not be eligible) at screening.

7.Subjects must refrain from donating sperm or fathering a child during the study and until 9 months after administration of BP02, EU-Herceptin or US-Herceptin administration by agreeing to use (with their female partner) 2 acceptable contraceptives.

8.Non-smokers or casual smokers who smoke no more than 5 cigarettes (or equivalent quantity of any other nicotine containing substance) per week. Subject must abstain from smoking 48 hours prior to admission to inpatient component of treatment period.

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria apply:
1.Known history of hypersensitivity or allergic reactions to trastuzumab or any of its excipients.
2.History of cardiovascular, hepatic, ophthalmic, pulmonary, neurological, metabolic, hematological, gastrointestinal, endocrine, immunological, psychiatric or any other disease which in the opinion of the Investigator would make the subject inappropriate for study participation.
3.Abnormal and clinically relevant (in the opinion of the Investigator) ECG, history of angina, exertional dyspnea, orthopnea, congestive heart failure, or myocardial infarction.
4.Subjects with LVEF of < 60 % on screening echocardiogram should be excluded from the study.
5.Sites are to adhere to local and institutional guidelines for exclusion of subjects with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and suspected coronavirus disease-2019 (COVID-19) infection/testing regarding the enrollment of subjects.
6.History of any cancer, including carcinoma in situ.
7.Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, or human immunodeficiency virus (HIV) I and II at screening.
8.Use of prescription or non-prescription drugs, including herbal and dietary supplements (including St. John’s Wort, grapefruit) within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study treatment, unless in the opinion of the Investigator, the medication will not interfere with the study procedures or compromise subject safety.
9.Use of hematopoietic growth factors, monoclonal antibodies, or immunoglobulins within 6 months prior to screening or 5 half-lives, whichever is longer.
10.Major surgery or major trauma within past one year of screening or anticipated need for any surgery during the study duration.
11.Difficulty in blood sampling or difficulty in accessibility of veins.
12.Prior history of or current alcohol abuse or excessive intake of alcohol as judged by the Investigator and/or a positive test result in breath alcohol done before check-in.
13.Subjects with a history of drug abuse or positive drug test at screening or admission.
14.Blood donation within 90 days prior to commencement of study and during the study.
15.Participation in an investigational antibody-based study within 6 months (from postdose follow-up) and any other investigational study within 90 days prior to dosing.
16.Participation in a study with trastuzumab or HER2 targeted antibody or any prior exposure to these drugs.
17.Subjects who, in the opinion of the Investigator, are not likely to complete the study for whatever reason.
18. Any persons who are:
- an employee of the Principal Investigator, clinical center, contract research organization (CRO) or Sponsor.
- a relative of an employee of the clinical center, the Investigators, CRO, or the Sponsor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
-Pharmacokinetic parameters Cmax , AUC0-t and AUC0-inf of trastuzumab in serum.<br>[-Preinfusion (or 0 h), At End of infusion (1.5 h), 0.5 h, 1 h, 4 h, and 6 h after the end of infusion, 24 h, 48 h, 72 h, and 96 h, Day 8 (168 h), Day 15 (336 h), Day 22 (504 h), Day 29 (672 h), Day 36 (840 h), Day 50 (1176 h), Day 64 (1512 h), and Day 78.]