A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(U.S. and German Sourced) in Healthy Chinese Male Subjects

A Phase I Study to Evaluate the Safety and Tolerability of Different Dosages of HLX02 (Open-label Part) and to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US and Germany Sourced; Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects

Assessment of safety of HLX02 at different doses. 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 German).

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Herceptin; Drug: HLX02

• Study Type: Interventional
• Enrollment (Actual): 123
• 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. Provide the singed informed consent form (ICF)
2. Healthy Chinese male subjects (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests)
3. Aged ≥18 and ≤45 years
4. Body mass index (BMI) ≥19 and ≤28 kg/m2
5. Weight ≥50 and ≤80 kg
6. Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation
7. Subjects must agree that they and their female spouse/partners will use reliable contraception (2 forms of birth control, one of which must be barrier method) or be of non-childbearing potential from the time of the administration of investigational product (IP) until the completion of the study
8. Do not smoke or smoke fewer than 5 cigarettes daily within three months prior to screening; do not drink or drink less than 14 units of alcohol within six months prior to screening (1 unit of alcohol = 360 mL beer or 45 mL spirits with 40% alcohol content or 150 mL wine)

Exclusion Criteria:

1. Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases
2. Clinically significant abnormalities in laboratory test results
3. Previous exposure to any monoclonal antibody or current use of any biologics
4. History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients
5. Use of prescription or non prescription drugs and dietary supplements, within 5 half-lives of the drug or supplement, or within 2 weeks prior to taking IP (whichever is longer). Herbal supplements must be discontinued 28 days prior to the IP
6. History of a blood donation within 3 months prior to the administration of IP
7. Have participated in any other clinical study within 3 months prior to the administration of IP
8. Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies
9. Have a history of drug abuse
10. Unlikely to comply with the protocol requirements, instructions, and study related restrictions; e.g., uncooperative attitude, inability to return for follow-up visits or improbability of completing the whole clinical study, etc.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: safety; Assessment of safety of HLX02 at different doses	Drug: HLX02
Active Comparator: PK comparative; 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 German)	Drug: Herceptin; Drug: HLX02

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
Adverse event frequencies	57 days
Area under the concentration-time curve from time zero to the last quantifiable concentration (AUClast)	57 days

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Publications and helpful links

General Publications

• Zhu X, Ding Y, Yu Y, Wang M, Zhou W, Wang J, Zhu X, Zhang H, Wang M, Chai K, Zhang X, Luk A, Jiang W, Liu S, Zhang Q. A Phase 1 randomized study compare the pharmacokinetics, safety and immunogenicity of HLX02 to reference CN- and EU-sourced trastuzumab in healthy subjects. Cancer Chemother Pharmacol. 2021 Mar;87(3):349-359. doi: 10.1007/s00280-020-04196-9. Epub 2020 Nov 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2015
• Primary Completion (Actual): May 11, 2016
• Study Completion (Actual): January 25, 2017

Study Registration Dates

• First Submitted: October 9, 2015
• First Submitted That Met QC Criteria: October 19, 2015
• First Posted (Estimate): October 21, 2015

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-HV01