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

NCT02581748 | Completed Phase 1 DMC

• 1 other identifier: HLX02-HV01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  57 days

Secondary Outcomes (4)

• 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

Study Arms (2)

safety

EXPERIMENTAL

Assessment of safety of HLX02 at different doses

Drug: HLX02

PK comparative

ACTIVE COMPARATOR

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: HLX02; Drug: Herceptin

Interventions

HLX02 DRUG

PK comparative; safety

Herceptin DRUG

PK comparative

Eligibility Criteria

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

You may qualify if:

• Provide the singed informed consent form (ICF)
• 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)
• Aged ≥18 and ≤45 years
• Body mass index (BMI) ≥19 and ≤28 kg/m2
• Weight ≥50 and ≤80 kg
• Left ventricular ejection fraction (LVEF) falls within the normal range as measured by echocardiogram (ECHO) within 14 days prior to randomisation
• 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
• 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)

You may not qualify if:

• Any history of clinically serious diseases such as hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, oncologic, or allergic diseases
• Clinically significant abnormalities in laboratory test results
• Previous exposure to any monoclonal antibody or current use of any biologics
• History of allergic or anaphylactic reactions including those occurred during any clinical study or those caused by any drug or any of its excipients
• 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
• History of a blood donation within 3 months prior to the administration of IP
• Have participated in any other clinical study within 3 months prior to the administration of IP
• Have positive test results for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or human immunodeficiency virus (HIV) antibodies
• Have a history of drug abuse
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

The Second Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Related Publications (1)

• 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.

  PMID: 33169186 DERIVED

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: October 9, 2015
• First Posted: October 21, 2015
• Study Start: September 16, 2015
• Primary Completion: May 11, 2016
• Study Completion: January 25, 2017
• Last Updated: June 3, 2022

Record last verified: 2022-06

Locations

CN (1)