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Bone TumorPhase 1NCT04178044

Phase Ⅰ Clinical Study Protocol of GB223 Monoclonal Antibody Injection

A Phase 1 study testing GB223,7mg/kg, GB223,21mg/kg and GB223,63mg/kg in people with Bone Tumor, run by Genor Biopharma Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Bone Tumor
What is being tested?
GB223,7mg/kg, GB223,21mg/kg and GB223,63mg/kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
16 Nov 2018to Apr 2021
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.)
Show all 21Show fewer
  • 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);
  • Subjects with positive tumor markers (CEA, AFP, PSA and CA-125);
  • Patients who previously or currently have malignant tumors within 5 years before screening (excluding adequately treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical in situ carcinoma);
  • Participated in other clinical studies within 3 months before enrollment, or subjects who received drugs which are known to injure the major organs within 3 months before enrollment;
  • Participated in clinical studies of similar investigational products such as denosumab etc.;
  • Use of drugs which may affect bone metabolism within 4 weeks or 5 half-lives (whichever is longer) before this study and the use of drugs which may affect bone metabolism during this study period; These drugs include but are not limited to the following drugs: contraceptives containing estrogen, bisphosphonate, fluoride, hormone replacement therapies (i.e., tibolone, estrogen, estrogenic compounds such as raloxifen), calcitonin, strontium, parathyroid hormone or its derivatives, vitamin D supplements (>1000IU/day), glucocorticoids (use of inhaled or local glucocorticoid 2 weeks before enrollment), anabolic hormone drugs (e.g., metandienone, nandrolone phenylpropionate, hydroxymetholone, stanozolol, nandrolone decanoate, danazolum), calcitriol and diuretics;
  • Subjects who are considered unsuitable for participating in this study for various reasons at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

Shawn Yu, Master contact

010-65260820

Shawn.Yu@genorbio.com

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510700

    Haiyan Liu, 13802736049, haiyanliu36049@Yeah.net

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Single-dose, Dose-escalated Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetic(PK) and Pharmacodynamic(PD) of GB223 in Healthy Adult Subjects.

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
Being tested
GB223,7mg/kg, GB223,21mg/kg, GB223,63mg/kg, GB223,119mg/kg, GB223,140mg/kg
Medical subject headings
Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB223,7mg/kgBiological

    Also called Placebo

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

  • GB223,21mg/kgBiological

    Also called Placebo

    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.

  • GB223,63mg/kgBiological

    Also called Placebo

    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.

  • GB223,119mg/kgBiological

    Also called Placebo

    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.

  • GB223,140mg/kgBiological

    Also called Placebo

    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.

Study groups in NCT04178044
Study groupRoleWhat they receive
GB223-group 1ExperimentalInjection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg,single dose administration; 2 subjects receive placebo.
Receives: Biological: GB223,7mg/kg
GB223-group 2Experimental21mg/kg
Receives: Biological: GB223,21mg/kg
GB223-group 3Experimental63mg/kg
Receives: Biological: GB223,63mg/kg
GB223-group 4Experimental119mg/kg
Receives: Biological: GB223,119mg/kg
GB223-group 5Experimental140mg/kg
Receives: Biological: GB223,140mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Effect, AE

    Adverse Effect, AE

    Measured: Up to 252 days

  2. Serious Adverse Effect, SAE

    Serious Adverse Effect, SAE

    Measured: Up to 252 days

  3. AUC0-t

    AUC0-t

    Measured: Up to 252 days

  4. Cmax

    Cmax

    Measured: Up to 252 days

  5. AUC0-∞

    AUC0-∞

    Measured: Up to 252 days

  6. Tmax

    Tmax

    Measured: Up to 252 days

  7. Vz/F

    Vz/F

    Measured: Up to 252 days

  8. Ke

    Ke

    Measured: Up to 252 days

  9. MRT

    MRT

    Measured: Up to 252 days

  10. t1/2z

    t1/2z

    Measured: Up to 252 days

  11. CLz/F

    CLz/F

    Measured: Up to 252 days

Secondary outcomes (1)

  1. AntiDrug Antibody, ADA

    AntiDrug Antibody, ADA

    Measured: Up to 252 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2019
  2. Study start16 Nov 2018
  3. Primary completionDec 2020 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04178044
Sponsor's protocol ID
GB223-001; V2.3; 16 Jan 2019
Status last verified
Nov 2019
First submitted
24 Nov 2019
Last updated
26 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37278972

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GB223,7mg/kg, GB223,21mg/kg and GB223,63mg/kg in people with Bone Tumor, run by Genor Biopharma Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Shawn Yu, Master (010-65260820, Shawn.Yu@genorbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Effect, AE (time frame: Up to 252 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04178044, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.

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