NCT04178044

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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 16, 2018

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 24, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 26, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

November 24, 2019

Last Update Submit

November 24, 2019

Conditions

Bone Tumor

Outcome Measures

Primary Outcomes (11)

  • Adverse Effect, AE

    Adverse Effect, AE

    Up to 252 days

  • Serious Adverse Effect, SAE

    Serious Adverse Effect, SAE

    Up to 252 days

  • AUC0-t

    AUC0-t

    Up to 252 days

  • Cmax

    Cmax

    Up to 252 days

  • AUC0-∞

    AUC0-∞

    Up to 252 days

  • Tmax

    Tmax

    Up to 252 days

  • Vz/F

    Vz/F

    Up to 252 days

  • Ke

    Ke

    Up to 252 days

  • MRT

    MRT

    Up to 252 days

  • t1/2z

    t1/2z

    Up to 252 days

  • CLz/F

    CLz/F

    Up to 252 days

Secondary Outcomes (1)

  • AntiDrug Antibody, ADA

    Up to 252 days

Study Arms (5)

GB223-group 1

EXPERIMENTAL

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

Biological: GB223,7mg/kg

GB223-group 2

EXPERIMENTAL

21mg/kg

Biological: GB223,21mg/kg

GB223-group 3

EXPERIMENTAL

63mg/kg

Biological: GB223,63mg/kg

GB223-group 4

EXPERIMENTAL

119mg/kg

Biological: GB223,119mg/kg

GB223-group 5

EXPERIMENTAL

140mg/kg

Biological: GB223,140mg/kg

Interventions

GB223,7mg/kgBIOLOGICAL

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

Also known as: Placebo
GB223-group 1
GB223,21mg/kgBIOLOGICAL

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.

Also known as: Placebo
GB223-group 2
GB223,63mg/kgBIOLOGICAL

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.

Also known as: Placebo
GB223-group 3
GB223,119mg/kgBIOLOGICAL

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.

Also known as: Placebo
GB223-group 4
GB223,140mg/kgBIOLOGICAL

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.

Also known as: Placebo
GB223-group 5

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Understand the study procedures and contents, and voluntarily sign the informed consent form;
  • Aged from 18 to 65 years at ICF signing (inclusive), males or females;
  • At screening, the male body weight≥50kg, female body weight ≥45kg, the body weight of males and females is not more than 75kg (inclusive), body mass index (BMI) is within the range between 19 and 24.0 (both inclusive);
  • The following tests are normal, or the abnormalities are not clinically significant at screening: physical examination, vital sign, laboratory tests, ECG test, chest radiography and CT tests of upper and middle abdomen, PPD test and CT test of oral cavity;
  • The subjects and their partners agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 12 months after the administration of investigational products.
  • The subjects can receive follow-up visits as scheduled, well communicate with the investigators and complete the study as required by the study.

You may not qualify if:

  • Lactating and pregnant women;
  • Subjects who have pregnancy plan within 12 months;
  • Subjects who currently or previously have osteomyelitis or osteonecrosis of jaws, or subjects who plan to receive invasive dental surgery or jaw surgery, or subjects whose wounds are not cured after dental or oral surgeries;
  • Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; subjects who have medical history of psychiatric disorders; subjects with medical history of hypertension or screening systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg, which are clinically significant at the discretion of the investigators; subjects who have medical history of orthostatic hypotension;
  • Any of the following is met: allergic constitution; known allergic to the components of the investigational product or allergy history to any drug or food or pollen; subjects who have abnormal serum immunoglobulin E (IgE) test;
  • Any of the current symptoms, signs or laboratory test abnormalities indicating the possible presence of acute or subacute infection (e.g., pyrexia, cough, urgent micturition, urodynia, abdominal pain, diarrhea, cutaneous infected wound etc.)
  • Subjects who have medical history of drug addiction or drug abuse;
  • Smoking more than 5 cigarettes/day or equivalent tobacco; or subjects who cannot stop smoking during the study period;
  • Weekly alcohol consumption more than 28 units (1 unit = 285 mL of beer or 25 mL of spirits or 100 mL of wine); or subjects who have positive breath alcohol test within 24 hours before the use of investigational drug;
  • Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5xULN, serum creatinine (Cr) \> 1.0xULN;
  • Abnormal routine blood tests: any of the following is met: white blood cells (WBC)\<3.0×109/L or \>9.15×109/L, neutrophil count (ANC)\<1.5×109/L, platelet count (PLT)\<100×109/L, hemoglobin (HGB)\<113g/L;
  • Abnormal serum calcium: current hypocalcaemia or hypercalcemia, or albumin-corrected serum calcium level is not within the normal laboratory range.
  • Any of the following is positive: hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-treponema pallidum antibody (TP-Ab);
  • Subjects with abnormal thyroid and parathyroid function and diseases affecting bone metabolism such as rheumatoid arthritis and osteomalacia;
  • Subjects with recent fracture (within 6 months);
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510700, China

RECRUITING

Related Publications (1)

  • Li C, Liu H, Liao Y, Zhu Y, Tian J, Wang X, Hu Z, Zhan Y, Li X, Liang X, He J, Li Y, Shang D, Zheng Q, Wang T, Song H, Fang Y. Phase I, Randomized, Placebo-Controlled, Dose-Escalation Study of GB223, a Fully-Humanized Monoclonal Antibody to RANKL, in Healthy Chinese Adults. BioDrugs. 2023 Sep;37(5):721-735. doi: 10.1007/s40259-023-00604-7. Epub 2023 Jun 6.

    PMID: 37278972DERIVED

MeSH Terms

Conditions

Bone Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Study Officials

  • Haiyan Liu, Bachelor

    Fifth Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shawn Yu, Master

CONTACT

010-65260820Shawn.Yu@genorbio.com

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 24, 2019

First Posted

November 26, 2019

Study Start

November 16, 2018

Primary Completion

December 1, 2020

Study Completion

April 1, 2021

Last Updated

November 26, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)