NCT04905667

Brief Summary

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 ®.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline
Completed

Started Nov 2019

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 13, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 2, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
Last Updated

May 27, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

March 2, 2021

Last Update Submit

May 25, 2021

Conditions

Breast Cancer

Keywords

Breast cancerPharmacokineticsanti-HER-2 human monoclonal antibodyHerceptinGB221

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (7)

  • Tmax

    Day 43

  • t1/2

    Day 43

  • CL

    Day 43

  • Vd

    Day 43

  • Ke

    Day 43

  • +2 more secondary outcomes

Study Arms (2)

GB221 group

EXPERIMENTAL

6 mg/kg, single dose, intravenous infusion, 90-100 min

Drug: GB221

Herceptin group

ACTIVE COMPARATOR

6 mg/kg, single dose, intravenous infusion, 90-100 min

Drug: Herceptin

Interventions

GB221DRUG

6 mg/kg, single dose, intravenous infusion, 90-100 min

GB221 group
HerceptinDRUG

6 mg/kg, single dose, intravenous infusion, 90-100 min

Herceptin group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Signed informed consent form;
  • \. Healthy adult volunteers aged between 18 and 45, male or female;
  • \. 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;
  • \. Agreed with taking reliable contraceptive measures, and no fertility planning from the beginning to the end of the study within 6 months;
  • Subject can communicate well with the investigators and complete the study according to the study regulations.

You may not qualify if:

  • \. 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;
  • \. Allergic constitution; or history of allergic to experimental drug ingredient or any drug or food or pollen; or abnormal serum immunoglobulin E (IgE) test;
  • \. History of drug abuse, or positive urine test for drug;
  • \. 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;
  • \. Family history of cancer, or tumor markers (male: CEA, AFP, PSA, CA-125; Female: CEA, AFP, CA-153, CA-125) positive.
  • \. Participated in other clinical trials of drug or used drugs harmful to major organs within 3 months;
  • \. Blood donation within 3 months;
  • \. Used prescription or OTC drugs within 14 days;
  • \. Left ventricular ejection fraction (LVEF) \< 60%;
  • \. ALT or AST \> 1.5 ULN, Cr \> ULN;
  • \. WBC \< 0.8 LLN or \> 1.2 ULN; ANC \< 0.8 LLN; PLT \< 0.8 LLN; HGB \< 0.9LLN.
  • \. HBs-Ag, HCV-Ab, anti-HIV or TP-Ab positive;
  • \. Anti-drug antibody (ADA) test positive;
  • History of psychosis;
  • \. History of postural hypotension;
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangzhou, 510799, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
double blind (Participant, Investigator)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2021

First Posted

May 27, 2021

Study Start

November 13, 2019

Primary Completion

September 8, 2020

Study Completion

September 11, 2020

Last Updated

May 27, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)