A Comparing Study Between ALT02(Trastuzumab Biosimilar) and Herceptin® in Healthy Subjects

NCT ID: NCT03242239

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-09
• Study Completion Date: 2016-09-30

Brief Summary

The purpose of this study is to compare ALT02 (Trastuzumab biosimilar) and Herceptin® (US-licensed Trastuzumab and EU-licensed Trastuzumab) in healthy male subjects about the pharmacokinetics, safety, tolerability and immunogenicity.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

ALT02

Group Type: EXPERIMENTAL

ALT02

Intervention Type: BIOLOGICAL

EU-licensed Herceptin

Group Type: ACTIVE_COMPARATOR

EU-licensed Herceptin

Intervention Type: BIOLOGICAL

US-licensed Herceptin

Group Type: ACTIVE_COMPARATOR

US-licensed Herceptin

Intervention Type: BIOLOGICAL

Interventions

ALT02

Intervention Type: BIOLOGICAL

EU-licensed Herceptin

Intervention Type: BIOLOGICAL

US-licensed Herceptin

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy male subjects
• Have a body weight over 50.0 kg and a body mass index over than 18.5 and less than 30.0 kg/m², inclusive.

Exclusion Criteria

• Any clinically significant abnormality or abnormal laboratory test results found during medical screening or positive test for hepatitis B, hepatitis C, or HIV found during medical screening.
• Positive urine drug screen or alcohol breath test at screening.
• History of allergic reactions to trastuzumab, benzyl alcohol, murine proteins, or other related drugs.
• Any reason which, in the opinion of the Qualified Investigator, would prevent the subject from participating in the study.
• Clinically significant electrocardiogram (ECG) abnormalities or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
• History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
• History of significant drug abuse within one year prior to screening or use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP], and crack) within 1 year prior to screening.
• Use of trastuzumab or another monoclonal antibody for a medical condition or in the context of another clinical trial.
• Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to dosing, administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving no drug or device administration.
• Use of medication other than topical products without significant systemic absorption:

1. prescription medication within 14 days prior to dose administration;

2. over-the-counter products including natural health products (e.g. food supplements and herbal supplements) within 7 days prior to dosing, with the exception of the occasional use of acetaminophen (up to 2 g daily);

3. a depot injection or an implant of any drug within 3 months prior to dose administration.

• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to dosing.
• Hemoglobin <128 g/L and hematocrit <0.37 L/L at screening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cristália Produtos Químicos Farmacêuticos Ltda.

INDUSTRY

Sponsor Role: collaborator

Alteogen, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ALT02

Identifier Type: -

Identifier Source: org_study_id