Status:
COMPLETED
A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Healthy
Eligibility:
MALE
18-45 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- Voluntarily signed Informed Consent Form
- 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)
- Aged ≥ 18 and ≤ 45 years
- Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2
- Body weight ≥ 50 and ≤ 80 kg
- LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (\>50%)
- Immunogenicity (anti-drug \[anti-trastuzumab\] antibody \[ADA\]) tested as negative
- 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
- Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor
- Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug
- History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study
- 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
- Donation of blood within 3 months prior to the administration of the study drug
- Participation in other clinical studies within 3 months prior to the administration of the study drug
- Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum
- History of drug abuse
- 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
- Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 4 2021
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT04670796
Start Date
March 2 2021
End Date
June 4 2021
Last Update
June 3 2022
Active Locations (1)
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1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China