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History of Changes for Study: NCT03794180
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
Latest version (submitted December 16, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 2, 2019 None (earliest Version on record)
2 January 4, 2019 Recruitment Status, Study Status and Contacts/Locations
3 March 19, 2019 Study Status
4 August 22, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
5 December 16, 2019 Recruitment Status and Study Status
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Study NCT03794180
Submitted Date:  March 19, 2019 (v3)

Open or close this module Study Identification
Unique Protocol ID: TJ003234RAR101
Brief Title: Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
Official Title: First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2019
Overall Status: Recruiting
Study Start: March 18, 2019
Primary Completion: August 2019 [Anticipated]
Study Completion: August 2019 [Anticipated]
First Submitted: December 28, 2018
First Submitted that
Met QC Criteria:
January 2, 2019
First Posted: January 4, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
March 19, 2019
Last Update Posted: March 21, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: I-Mab Biopharma Co. Ltd.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
Brief Summary: TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).
Detailed Description:
Open or close this module Conditions
Conditions: Healthy Adult Subjects
Keywords: Anti-GM-CSF agents
GM-CSF/GM-CSFR (GM-CSF receptor) antibody
colony-stimulating factor 2
monoclonal antibody
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 32 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: TJ003234
0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion
Drug: TJ003234
Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
Placebo Comparator: Placebo
0 mg/kg via single IV infusion
Drug: Placebo
Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety Profile: AEs
[ Time Frame: Up to 85 days after study drug administration ]

Incidence of Adverse Events (AEs)
2. Maximum Tolerated Dose
[ Time Frame: Up to 85 days after study drug administration ]

Determine Maximum Tolerated Dose of TJ003234
Secondary Outcome Measures:
1. Pharmacokinetic (PK) Parameters: Tmax
[ Time Frame: Up to 85 days after study drug administration ]

Time of peak concentration (Tmax)
2. Pharmacokinetic (PK) Parameters: Cmax
[ Time Frame: Up to 85 days after study drug administration ]

Maximal Concentration (Cmax)
3. Pharmacokinetic (PK) Parameters: T1/2
[ Time Frame: Up to 85 days after study drug administration ]

Investigational product (IP) half-life (T1/2)
4. Pharmacokinetic (PK) Parameters: CL
[ Time Frame: Up to 85 days after study drug administration ]

Investigational Product (IP) Clearance (CL)
5. Pharmacokinetic (PK) Parameters: AUC∞
[ Time Frame: Up to 85 days after study drug administration ]

Area under the curve from time zero extrapolated to infinity (AUC∞)
6. Anti-drug antibodies (ADA)
[ Time Frame: Up to 85 days after study drug administration ]

Incidence and concentration of anti-drug antibodies
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: Yes
Criteria:

Inclusion Criteria:

  • Able to understand and willing to sign the informed consent form (ICF)
  • Healthy subjects 18-70 years of age
  • If of childbearing potential, agree to use protocol-specified contraception
  • Body mass index (BMI) 19.0-32.0 kg/m^2
  • Blood pressure ≤ 139/89 mm Hg
  • Subjects are able to follow the study protocol and complete the trial

Exclusion Criteria:

  • Current use of tobacco or nicotine-containing products or illicit drug use
  • History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies
  • Any known pulmonary disease
  • Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study
  • Abnormal hematological and chemistry laboratory values >10% above upper limit of normal (ULN) or >10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) ≤ 1000 cells/mm^3
  • Use of any biologic drugs in the last 120 days prior to dosing.
  • Immunization with a live or attenuated vaccine within 4 weeks prior to study drug administration
  • Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists
  • ADA screening positive
  • Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents
  • A positive alcohol test and/or urine drug screen for substance of abuse at screening or upon check-in to the clinical site
Open or close this module Contacts/Locations
Central Contact Person: US Site Head
Telephone: 301-294-4408
Email: US.Info@I-MabBiopharma.com
Study Officials: Claire Xu, MD, PhD
Study Director
I-Mab Biopharma
Locations: United States, Maryland
Pharmaron
[Recruiting]
Baltimore, Maryland, United States, 21201
Contact:Contact: Jason Ferrante 410-706-8946 Jason.Ferrante@pharmaron-us.com
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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