Clinical Trial of Comparative Study of GB221 Pharmacokinetics

NCT04175171 | Completed Phase 1

• 1 other identifier: GB221-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (7)

• physical examination

  physical examination

  Up to 84 days

• adverse event

  adverse event

  Up to 84 days

• blood pressure

  blood pressure

  Up to 84 days

• heart rate

  heart rate

  Up to 84 days

• respiration rate

  respiration rate

  Up to 84 days

• oxygen saturation

  oxygen saturation

  Up to 84 days

• temperature

  temperature

  Up to 84 days

Secondary Outcomes (6)

• C max

  Up to 84 days

• t max

  Up to 84 days

• AUC

  Up to 84 days

• CL

  Up to 84 days

• t ½

  Up to 84 days

Study Arms (2)

GB221

EXPERIMENTAL

Coprelotamab Injection, 8mg/kg, single dose

Drug: Coprelotamab Injection

Herceptin

ACTIVE COMPARATOR

Trastuzumab Injection, 8mg/kg, single dose

Drug: Trastuzumab Injection

Interventions

Coprelotamab Injection DRUG

The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.

Also known as: GB221

GB221

Trastuzumab Injection DRUG

The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.

Also known as: Herceptin

Herceptin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be enrolled in the study, subjects must meet the following criteria
• Males aged 18 to 45 years.
• Healthy as judged by medical examination and medical history, and clinical chemistry and hematology screening.
• Body weight within the normal range for height (BMI between 19.0 and 29.0, inclusive) up to a maximum of 90 kg.
• Normal or non-clinically significant ECG.
• Normotensive (systolic: 90 - 140; diastolic: 50 - 90 mm Hg, inclusive) and heart rate (40 -100 bpm, inclusive).
• Willingness to give written and informed consent prior to any studyrelated procedures being conducted

You may not qualify if:

• Subjects will be ineligible for the study if any of the following criteria apply:
• Receipt of any investigational agent or drug within 4 weeks of entry to the study.
• Use of any medicine - prescription, over-the-counter or herbal - in the 7 days prior to the treatment day and until 12 weeks after the treatment day.
• Donation of blood (or loss of blood) greater than 400 ml within 3 months of the study.
• Clinically significant drug allergy or sensitivity to any medication.
• A history of chronic or recurrent infections.
• A recent history of surgery.
• History or presence of malignancy (with the exception of successfully treated basal cell carcinoma).
• Inability to communicate or cooperate with the Principal Investigator because of English language difficulties or poor mental development.
• A history (within the last 5 years) or evidence of alcohol or drug abuse (excepting tobacco use less than 10 cigarettes per day).
• A positive urine test for drugs of abuse or alcohol either at screening or on the day of admittance for drug administration.
• Vaccination of any type within the previous month.
• A history of major psychiatric illness (such as bipolar disorder, schizophrenia or persistent major depression). Previous minor depression/adjustment disorder is acceptable if currently asymptomatic.
• Consumption of more than 3 standard drinks per day, and not able to abstain from alcohol totally within 24 hours of dose administration.
• Presence of current infection with tuberculosis, Hepatitis B, Hepatitis C or HIV.

Sponsors & Collaborators

• Genor Biopharma Co., Ltd.: lead

Study Sites (1)

Linear Clinical Research Limited

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Andrewn Redfer, PhD; MBBS

  Linear Clinical Research Limited

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: November 22, 2019
• Study Start: November 7, 2011
• Primary Completion: January 8, 2012
• Study Completion: March 8, 2012
• Last Updated: December 18, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)