Clinical trial NCT04670796: A Safety and Pharmacokinetic Study Between HLX02 and Herceptin®(US-licensed and EU-approved) in Healthy Chinese Male Subjects
Official title: A Phase I Study to Compare the Pharmacokinetics, Safety, Tolerability, and Immunogenicity Between HLX02 and Herceptin® (US-licensed and EU-approved Reference Products, Double-blind, Randomized, Parallel-group Part) in Healthy Chinese Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Shanghai Henlius Biotech
Sponsor class: INDUSTRY
First posted: 2020-12-17
Enrollment: 111
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Voluntarily signed Informed Consent Form
2. 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)
3. Aged ≥ 18 and ≤ 45 years
4. Body mass index (BMI) ≥ 19 and ≤ 28 kg/m2
5. Body weight ≥ 50 and ≤ 80 kg
6. LVEF within normal range as examined through echocardiogram within 14 days prior to randomization (\>50%)
7. Immunogenicity (anti-drug \[anti-trastuzumab\] antibody \[ADA\]) tested as negative
8. 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

Exclusion Criteria:

1. Any clinically serious disease history or allergic disease, such as hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, mental and nervous diseases and tumor
2. Use of monoclonal antibodies or any biological agent within 6 months prior to the administration of the study drug
3. History of allergic reactions, including allergic reactions caused by any drug or excipient in clinical study
4. 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
5. Donation of blood within 3 months prior to the administration of the study drug
6. Participation in other clinical studies within 3 months prior to the administration of the study drug
7. Positive test result(s) for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and treponema pallidum
8. History of drug abuse
9. 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
10. Subject confirmed SARS-CoV-2 infection by appropriate test (including but not limited to nucleic acid test) in screening period

Primary outcomes:
measure: Area under the concentration-time curve from time zero to infinity (AUCinf)
timeFrame: 57 days
Secondary outcomes:
measure: Maximum serum concentration (Cmax)
timeFrame: 57 days
measure: time to Cmax (Tmax)
timeFrame: 57 days
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: