Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects

Healthy Male Volunteers Clinical Trial

Official title:

A (Randomised, Double-Blind, Intravenous Single-Dose, Parallel, Four-Arm) Phase I Clinical Study to Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta® (US, EU, and CN-Sourced) in Healthy Chinese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04411550
• Other study ID #: HLX11-001
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: April 2022
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 30, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy Chinese males
• aged = 18 and = 45
• body mass index (BMI) = 19 and = 26 kg/m2
• LVEF= 55%

Exclusion Criteria:

• A history of any serious clinical disease such as haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental, neurological diseases, and tumour, or allergic diseases
• Use of a monoclonal antibody or any biological product within 6 months before study drug administration
• A history of allergic reactions or anaphylaxis, including such reactions to any drug or excipient in the clinical study
• Use of prescription drugs, over-the-counter drugs (OTC), or traditional Chinese medicine (TCM) (excluding vitamins, mineral supplements, and dietary supplements) within 28 days before study drug administration
• A history of blood donation within 3 months before study drug administration
• Participation in other clinical study and use of the investigational product/comparator within 3 months before study drug administration
• Positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or treponema pallidum antibody
• A history of drug abuse
• Failure to comply with protocol requirements, instructions, and study limitations, such as uncooperative attitude, failure to return to the study site for follow-up visits, or failure to complete the entire clinical study, as judged by investigators

Related Conditions & MeSH terms

• Healthy Male Volunteers

Intervention

Drug:
• HLX11
healthy volunteers receive HLX11 (420mg) once
• CN-Perjeta(Pertuzumab)
healthy volunteers receive CN-Perjeta (420mg) once
• EU-Perjeta(Pertuzumab)
healthy volunteers receive EU-Perjeta (420mg) once
• US-Perjeta(Pertuzumab)
healthy volunteers receive US-Perjeta (420mg) once

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

References & Publications (1)

American Society for Clinical Pharmacology and Therapeutics. Clin Pharmacol Ther. 2022 Mar;111 Suppl 1:S5-S80. doi: 10.1002/cpt.2521. Erratum in: Clin Pharmacol Ther. 2022 Apr 17;:. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Peak concentration	from predose to 2352 hours (Day 99),13 timepoints
Primary	AUC0~t	Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point	from predose to 2352 hours (Day 99),13 timepoints
Primary	AUC0~inf	Area under the plasma concentration-time curve from time 0 to infinity	from predose to 2352 hours (Day 99),13 timepoints
Secondary	safety and tolerability of 4 groups	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	from day1 to day 99
Secondary	safety and tolerability of 4 groups	Number of AE as assessed by CTCAE v5.0	from day1 to day 99
Secondary	safety and tolerability of two groups	AE listing as assessed by CTCAE v5.0	from day1 to day 99