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

NCT04670796 | Completed Phase 1

• 1 other identifier: HLX02-HV02
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Area under the concentration-time curve from time zero to infinity (AUCinf)

  57 days

Secondary Outcomes (2)

• Maximum serum concentration (Cmax)

  57 days

• time to Cmax (Tmax)

  57 days

Study Arms (3)

HLX02

EXPERIMENTAL

patient receive one dose of HLX02

Drug: HLX02

EU-sourced Trastuzumab (Herceptin®)

ACTIVE COMPARATOR

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

Drug: EU-sourced Trastuzumab (Herceptin®)

US-licensed Trastuzumab (Herceptin®)

ACTIVE COMPARATOR

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

Drug: US-licensed Trastuzumab (Herceptin®)

Interventions

HLX02 DRUG

subject receive one dose of HLX02

HLX02

EU-sourced Trastuzumab (Herceptin®) DRUG

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

EU-sourced Trastuzumab (Herceptin®)

US-licensed Trastuzumab (Herceptin®) DRUG

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

US-licensed Trastuzumab (Herceptin®)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

MeSH Terms

Interventions

Trastuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: March 2, 2021
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: June 3, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)