A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects

NCT ID: NCT04670796

Last Updated: 2022-06-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-02
• Study Completion Date: 2021-06-04

Brief Summary

Randomised, double-blind, parallel group Phase I study to compare PK profiles and to assess the safety and immunogenicity between HLX02 and Herceptin® (U.S. and EU).

Conditions

Healthy

Study Design

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

Study Groups

US-licensed Trastuzumab (Herceptin®)

patient receive one dose of US-licensed Trastuzumab (Herceptin®)

Group Type: ACTIVE_COMPARATOR

US-licensed Trastuzumab (Herceptin®)

Intervention Type: DRUG

subject receive one dose of US-licensed Trastuzumab (Herceptin®)

HLX02

patient receive one dose of HLX02

Group Type: EXPERIMENTAL

HLX02

Intervention Type: DRUG

subject receive one dose of HLX02

EU-sourced Trastuzumab (Herceptin®)

patient receive one dose of EU-sourced Trastuzumab (Herceptin®)

Group Type: ACTIVE_COMPARATOR

EU-sourced Trastuzumab (Herceptin®)

Intervention Type: DRUG

subject receive one dose of EU-sourced Trastuzumab (Herceptin®)

Interventions

HLX02

subject receive one dose of HLX02

Intervention Type: DRUG

EU-sourced Trastuzumab (Herceptin®)

subject receive one dose of EU-sourced Trastuzumab (Herceptin®)

Intervention Type: DRUG

US-licensed Trastuzumab (Herceptin®)

subject receive one dose of US-licensed Trastuzumab (Herceptin®)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Voluntarily signed Informed Consent Form

2. Healthy Chinese male (healthy is defined as the fact that no clinically significant abnormalities are identified by medical history, physical examination, vital signs, chest X ray, 12-lead ECG and laboratory tests)

3. Aged ≥ 18 and ≤ 45 years

4. Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2

5. Body weight ≥ 50 and ≤ 80 kg

6. LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (>50%)

7. Immunogenicity (anti-drug [anti-trastuzumab] antibody [ADA]) tested as negative

8. Subject agrees that he and his female spouse/partner use reliable contraceptive methods from the time of administration of study drug until 3 months after the end of study, or subject is infertile

Exclusion Criteria

1. Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor

2. Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug

3. History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study

4. Use of any prescription or non-prescription drug or dietary supplement within 5 half lives of such drug or dietary supplement or 2 weeks prior to the administration of the study drug (whichever is longer). The traditional Chinese medicine-based dietary supplement should be discontinued 28 days prior to administration of the study drug

5. Donation of blood within 3 months prior to the administration of the study drug

6. Participation in other clinical studies within 3 months prior to the administration of the study drug

7. Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum

8. History of drug abuse

9. Inability to follow the protocol requirements, instructions and study limitations as judged by investigators, such as noncooperation, inability to return to the site for follow-up visits or inability to complete the whole clinical study

10. Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

HLX02-HV02

Identifier Type: -

Identifier Source: org_study_id