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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: HLX02; Drug: EU-sourced Trastuzumab (Herceptin®); Drug: US-licensed Trastuzumab (Herceptin®)

• Study Type: Interventional
• Enrollment (Actual): 111
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China
      • The Second Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX02; patient receive one dose of HLX02	Drug: HLX02; subject receive one dose of HLX02
Active Comparator: EU-sourced Trastuzumab (Herceptin®); patient receive one dose of EU-sourced Trastuzumab (Herceptin®)	Drug: EU-sourced Trastuzumab (Herceptin®); subject receive one dose of EU-sourced Trastuzumab (Herceptin®)
Active Comparator: US-licensed Trastuzumab (Herceptin®); patient receive one dose of US-licensed Trastuzumab (Herceptin®)	Drug: US-licensed Trastuzumab (Herceptin®); subject receive one dose of US-licensed Trastuzumab (Herceptin®)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve from time zero to infinity (AUCinf)	57 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum serum concentration (Cmax)	57 days
time to Cmax (Tmax)	57 days

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Actual): June 4, 2021
• Study Completion (Actual): June 4, 2021

Study Registration Dates

• First Submitted: December 10, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: HLX02-HV02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No