Status:
COMPLETED
Compare Pharmacokinetics, Safety, and Immunogenicity of HLX11 vs. Perjeta in Healthy Chinese Male Subjects
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Healthy Male Volunteers
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- Healthy Chinese males
- aged ≥ 18 and ≤ 45
- body mass index (BMI) ≥ 19 and ≤ 26 kg/m2
- LVEF≥ 55%
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04411550
Start Date
July 1 2020
End Date
July 30 2021
Last Update
May 11 2022
Active Locations (1)
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1
The Second Hospital of Anhui Medical University
Hefei, Anhui, China