Single Dose Pharmacokinetic Study of GB221 in Comparison With Herceptin ®

A Single Center, Randomized, Blind, Parallel Controlled, Single Dose Pharmacokinetic Study of Recombinant Humanized Anti-HER-2 Monoclonal Antibody Injection GB221 in Comparison With Herceptin ® in Chinese Healthy Adult Volunteers

This is a single center, randomized, blind, parallel controlled clinical trial. The primary objective is to evaluate the single dose pharmacokinetics of recombinant Humanized anti-HER-2 monoclonal antibody injection GB221 in comparison with Herceptin ® in Chinese healthy adult volunteers. The main aim is to study the pharmacokinetic similarity between GB221 and Herceptin ®.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: GB221; Drug: Herceptin

Detailed Description

Subjects will enroll in random order, and be divided into two groups, then receive a single dose (6 mg/kg) of GB221 or Herceptin ®, and accept observation for 42 days. Throughout the course, safety data will be collected.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510799
      • The Fifth Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 1. Signed informed consent form;
• 2. Healthy adult volunteers aged between 18 and 45, male or female;
• 3. Medical examination as required within 28 days, body mass index (BMI) 19.0 ~ 24.0, weight≥50 kg for men, ≥45 kg for women, and≤ 75 kg for both;
• 4. Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
• 5.Subject can communicate well with the investigators and complete the study according to the study regulations.

Exclusion Criteria:

• 1. Pregnant or lactating women, or positive in either blood or urine pregnancy test; or unwilling to take effective contraceptive measures during the trial and within 6 months after the end of the trial at fertile age;
• 2. Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
• 3. History of drug abuse, or positive urine test for drug;
• 4. History of the central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system or other significant diseases. History of high blood pressure, or clinically significant systolic blood pressure≥140 mmHg/diastolic blood pressure≥90 mmHg;
• 5. Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
• 6. Participated in other clinical trials of drug or used drugs harmful to major organs within 3 months;
• 7. Blood donation within 3 months;
• 8. Used prescription or OTC drugs within 14 days;
• 9. Left ventricular ejection fraction (LVEF) < 60%;
• 10. ALT or AST > 1.5 ULN, Cr > ULN;
• 11. WBC < 0.8 LLN or > 1.2 ULN; ANC < 0.8 LLN; PLT < 0.8 LLN; HGB < 0.9LLN.
• 12. HBs-Ag, HCV-Ab, anti-HIV or TP-Ab positive;
• 13. Anti-drug antibody (ADA) test positive;
• 14.History of psychosis;
• 15. History of postural hypotension;
• 16. More than 5 cigarettes per day;
• 17. More than 28 units of alcohol per week; Or alcohol breath test positive within 24 hours before pre-dose;
• 18. History of dizziness of blood or needle;
• 19. Unsuitable for other reasons.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GB221 group; 6 mg/kg, single dose, intravenous infusion, 90-100 min	Drug: GB221; 6 mg/kg, single dose, intravenous infusion, 90-100 min
ACTIVE_COMPARATOR: Herceptin group; 6 mg/kg, single dose, intravenous infusion, 90-100 min	Drug: Herceptin; 6 mg/kg, single dose, intravenous infusion, 90-100 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	compare the pharmacokinetic AUC0-t parameters of GB221 and Herceptin ®	Day 43
AUC0-∞	compare the pharmacokinetic AUC0-∞parameters of GB221 and Herceptin ®	Day 43
Cmax	compare the pharmacokinetic Cmax parameters of GB221 and Herceptin ®	Day 43

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	compare the pharmacokinetic Tmax parameters of GB221 and Herceptin ®	Day 43
t1/2	compare the pharmacokinetic t1/2 parameters of GB221 and Herceptin ®	Day 43
CL	compare the pharmacokinetic CL parameters of GB221 and Herceptin ®	Day 43
Vd	compare the pharmacokinetic Vd parameters of GB221 and Herceptin ®	Day 43
Ke	compare the pharmacokinetic Ke parameters of GB221 and Herceptin ®	Day 43
ADA	compare the incidence of ADA in of GB221 and Herceptin ® group	Day 43
Nab	compare the incidence of Nab in of GB221 and Herceptin ® group	Day 43

Collaborators and Investigators

• Sponsor: Genor Biopharma Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2019
• Primary Completion (ACTUAL): September 8, 2020
• Study Completion (ACTUAL): September 11, 2020

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (ACTUAL): May 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 25, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Breast cancer; Herceptin; anti-HER-2 human monoclonal antibody; GB221
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab
• Other Study ID Numbers: 221-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No