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Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

NCT04178044 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-11-26

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single dose of GB223 in healthy subjects; the secondary objective is to evaluate the immunogenicity and pharmacodynamic (PD) profiles of single dose of GB223 in healthy subjects.

Conditions

  • Bone Tumor

Interventions

BIOLOGICAL

GB223,7mg/kg

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg 2 subjects receive placebo.

BIOLOGICAL

GB223,21mg/kg

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:21mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.

BIOLOGICAL

GB223,63mg/kg

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:63mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.

BIOLOGICAL

GB223,119mg/kg

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:119mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.

BIOLOGICAL

GB223,140mg/kg

Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:140mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.

Sponsors & Collaborators

  • Genor Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Haiyan Liu, Bachelor · Fifth Affiliated Hospital of Guangzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-16
Primary Completion
2020-12-31
Completion
2021-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178044 on ClinicalTrials.gov