A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

Shanghai Henlius Biotech1 site in 1 country111 target enrollmentMarch 2, 2021

ConditionsHealthy

InterventionsHLX02 EU-sourced Trastuzumab (Herceptin®)US-licensed Trastuzumab (Herceptin®)

DrugsHLX02 EU-sourced Trastuzumab (Herceptin®)US-licensed Trastuzumab (Herceptin®)

Overview

Phase: Phase 1
Intervention: HLX02
Conditions: Healthy
Sponsor: Shanghai Henlius Biotech
Enrollment: 111
Locations: 1
Primary Endpoint: Area under the concentration-time curve from time zero to infinity (AUCinf)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 2, 2021

End Date

June 4, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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