Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection

NCT05323981 | Completed Phase 1

• 1 other identifier: HS627-TBE
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single intravenous administration in healthy subjects

Conditions

Similarity of Pharmacokinetics and Safety

Outcome Measures

Primary Outcomes (1)

• （AUC0-∞）of HS627(2 specifications) and PERJETA

  Area under the concentration-time curve (AUC0 - ∞) from 0 to infinity of HS627(2 specifications) and PERJETA

  85Days

Secondary Outcomes (6)

• （AUC0-t）of HS627(2 specifications) and PERJETA

  85Days

• Cmax

  85Days

• Tmax

  85Days

• CL

  85Days

• T1/2

  85Days

Study Arms (3)

HS627(210mg/7ml)

EXPERIMENTAL

Drug: HS627(210mg/7ml)

HS627(420mg/14ml)

EXPERIMENTAL

Drug: HS627(420mg/14ml)

PERJETA

ACTIVE COMPARATOR

Drug: Perjeta

Interventions

HS627(210mg/7ml) DRUG

Intravenous drip of 420mg HS627

HS627(210mg/7ml)

HS627(420mg/14ml) DRUG

Intravenous drip of 420mg HS627

HS627(420mg/14ml)

Perjeta DRUG

Intravenous drip of 420mg PERJETA

PERJETA

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Signing the informed consent and being able to complete the test according to the plan;
• \. Aged \>= 18 and \<= 40 (subject to the day of signing informed consent), male;
• \. BMI is between 20\~25 kg/m2 (including 20 kg/m2 and 25 kg/m2), and the weight is between 50-70kg (including 50kg and 70kg);
• \. The left ventricular ejection fraction (LVEF) was more than 50% by echocardiography within 2 weeks before drug administration;
• \. During the trial period and within 6 months after the infusion, the subjects or their spouses should take appropriate and effective contraceptive measures, such as abstinence and double barrier method (such as condom and diaphragm), oral contraceptive pill and IUD placement

You may not qualify if:

• \. Patients with mental, respiratory, cardiovascular, digestive, urinary, reproductive, skeletal and motor diseases, blood, endocrine, nervous and other system diseases, and the judgment of the researchers has an impact on the pharmacokinetic results or safety;
• \. Those who have a history of allergy to pertuzumab or any of its auxiliary materials or food; or who have a history of specific allergy (asthma, urticaria, eczema dermatitis, etc.); or who are allergic to the apparatus (such as syringe needle or intravenous drip needle, or intravenous drip hose) needed in the test;
• Those who have special requirements for diet and cannot follow the unified diet;
• Serious bleeding factors affecting peripheral venous blood collection;
• \. Patients with history of malignancy;
• \. Having previously received any antibody treatment targeting HER2 receptor or used monoclonal antibody within 6 months before signing informed consent;
• \. Vaccinated with any live vaccine within 6 months before signing the informed consent;
• \. Alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 units of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol or 2100 ml wine), or whose breath alcohol test is positive;
• \. Have used soft drugs (such as marijuana) within 3 months before signing informed consent or hard drugs within 1 year before signing the informed consent (e.g. cocaine, phencyclidine, etc.); drug abuse test positive (morphine, Amphetamine, ketamine, dimethylene dioxoamphetamine, tetrahydrocannabinolic acid);
• \. Within 3 months prior to signing the informed consent, he had blood donation history or lost more than 400ml of blood, received blood transfusion or had used blood products; those who lost more than 200 ml blood within one month before signing the informed consent;
• \. Those who have participated in other clinical trials and used the experimental drugs or instruments within 3 months before signing the informed consent;
• \. Those who are addicted to smoking or have more than 5 cigarettes per day on average within three months before signing the informed consent;
• \. Those who have undergone surgery within 2 months before signing the informed consent;
• \. Those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, proprietary Chinese medicine, vitamins, dietary supplements, etc.) and health care products within 14 days prior to signing the informed consent, or whose previous treatment drug(s) is(are) still within 5 half-lives when using the experimental drugs;
• \. Patients with upper respiratory tract infection or other acute infections within 2 weeks before screening;

Sponsors & Collaborators

• BioRay Pharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, 266000, China

Location

MeSH Terms

Interventions

pertuzumab

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: April 11, 2022
• Primary Completion: October 9, 2022
• Study Completion: October 9, 2022
• Last Updated: July 11, 2023

Record last verified: 2023-07

Locations

CN (1)