NCT04178070

Brief Summary

The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult 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
58

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Nov 2017

Longer than P75 for phase_1 rheumatoid-arthritis

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 6, 2017

Completed
2 years 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 27, 2019

Status Verified

November 1, 2019

Enrollment Period

3.1 years

First QC Date

November 24, 2019

Last Update Submit

November 25, 2019

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

  • Adeverse Effect, AE

    Adeverse Effect, AE

    Up to 112 days.

  • Serious Adeverse Effect, AE

    Serious Adeverse Effect, AE

    Up to 112 days.

  • Maximum Tolerated Dose, MTD

    Maximum Tolerated Dose, MTD

    Up to 112 days.

  • Dose Limited Toxicity, DLT

    Dose Limited Toxicity, DLT

    Up to 112 days.

Secondary Outcomes (9)

  • AUC0-t

    Up to 112 days.

  • Cmax

    Up to 112 days.

  • AUC0-∞

    Up to 112 days.

  • Tmax

    Up to 112 days.

  • Vd

    Up to 112 days.

  • +4 more secondary outcomes

Study Arms (12)

GB224 2mg

EXPERIMENTAL

single dose

Biological: GB224 2mg

GB224 5mg

EXPERIMENTAL

single dose

Biological: GB224 5mg

GB224 10mg

EXPERIMENTAL

single dose

Biological: GB224 10mg

GB224 15mg

EXPERIMENTAL

single dose

Biological: GB224 15mg

GB224 20mg

EXPERIMENTAL

single dose

Biological: GB224 20mg

GB224 30mg

EXPERIMENTAL

single dose

Biological: GB224 30mgOther: Placebo, 30mg

Placebo 2mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 2mg

Placebo 5mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 5mg

Placebo 10mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 10mg

Placebo 15mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 15mg

Placebo 20mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 20mg

Placebo 30mg

PLACEBO COMPARATOR

single dose

Other: Placebo, 30mg

Interventions

GB224 2mgBIOLOGICAL

2mg (100μL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 2mg
GB224 5mgBIOLOGICAL

5mg (250μL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 5mg
GB224 10mgBIOLOGICAL

10mg (500μL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 10mg
GB224 15mgBIOLOGICAL

15mg (750μL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 15mg
GB224 20mgBIOLOGICAL

20mg (1mL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 20mg
GB224 30mgBIOLOGICAL

30mg (1.5mL), single dose, abdominal subcutaneous injection

Also known as: Gerilimzumab injection
GB224 30mg
Placebo, 2mgOTHER

2mg (100μL), single dose, abdominal subcutaneous injection

Placebo 2mg
Placebo, 5mgOTHER

5mg (250μL), single dose, abdominal subcutaneous injection

Placebo 5mg
Placebo, 10mgOTHER

10mg (500μL), single dose, abdominal subcutaneous injection

Placebo 10mg
Placebo, 15mgOTHER

15mg (750μL), single dose, abdominal subcutaneous injection

Placebo 15mg
Placebo, 20mgOTHER

20mg (1mL), single dose, abdominal subcutaneous injection

Placebo 20mg
Placebo, 30mgOTHER

30mg (1.5mL), single dose, abdominal subcutaneous injection

GB224 30mgPlacebo 30mg

Eligibility Criteria

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

You may qualify if:

  • Understand the study procedures and contents, and voluntarily sign the informed consent form;
  • Chinese healthy adult volunteers aged 18 to 45 years, males and females;
  • The subjects have qualified physical examination within 30 days before the study, the body mass index (BMI) is within the range of 19\~24 and the body weight is within the range of 45\~75kg;
  • Males or females agree to adopt medically confirmed effective contraceptive measures during the entire study period and within 6 months after the end of this study.
  • The investigator considers that the patients have good health condition according to the physical examination, medical history, vital signs and ECG etc.
  • Patients have good compliance, can receive follow-up visits as scheduled, are able to well communicate with the investigators and complete the study as required by the study.

You may not qualify if:

  • 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 medical history of skin allergy such as physical urticaria; 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.)
  • Patients with active pulmonary tuberculosis; patients who previously had medical history of active pulmonary tuberculosis;
  • Subjects who have medical history of drug addiction or drug abuse;
  • Subjects who have clear medical history of central nervous system, cardiovascular, renal, hepatic, gastrointestinal, respiratory, metabolic system or subjects with other significant diseases; 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;
  • Subjects who have medical history of malignant tumors;
  • Subjects who 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;
  • Subjects who used prescription drugs or non-prescription drugs within 14 days before enrollment;
  • Subjects who have blood donation history within 3 months before enrollment;
  • Subjects who meet any of the following criteria: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 times the upper limit of normal (ULN), serum creatinine (Cr) \> the upper limit of normal (ULN);
  • Abnormal routine blood tests: any of the following is met: white blood cells (WBC)\<3.0×109/L or \>9.5×109/L, neutrophil count (ANC)\<1.5×109/L, platelet count (PLT)\<100×109/L, hemoglobin (HGB)\<104g/L;
  • 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 who have positive tuberculosis skin test (5 units of dosage, induration of not less than 5 millimeters (mm) within 48 \~ 72 hours);
  • Subjects with positive anti-nuclear antibody (ANA), anti-double stranded DNA antibody (ds-DNA) and anti-extractable nuclear antigens (ENA);
  • Subjects with positive anti-drug antibody (ADA);
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Yi Fang, Ph.D

    Peking University People's Hospital

    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 6, 2017

Primary Completion

December 1, 2020

Study Completion

April 1, 2021

Last Updated

November 27, 2019

Record last verified: 2019-11

Locations

CN(1)