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Trial record 1 of 1 for:    NCT03794180
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Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects

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ClinicalTrials.gov Identifier: NCT03794180
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
I-Mab Biopharma Co. Ltd.

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).

Condition or disease Intervention/treatment Phase
Healthy Adult Subjects Drug: TJ003234 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 18, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794180


Locations
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United States, Maryland
Pharmaron
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
I-Mab Biopharma Co. Ltd.
Investigators
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Study Director: Claire Xu, MD, PhD I-Mab Biopharma

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Responsible Party: I-Mab Biopharma Co. Ltd.
ClinicalTrials.gov Identifier: NCT03794180     History of Changes
Other Study ID Numbers: TJ003234RAR101
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by I-Mab Biopharma Co. Ltd.:
Anti-GM-CSF agents
GM-CSF/GM-CSFR (GM-CSF receptor) antibody
colony-stimulating factor 2
monoclonal antibody
Additional relevant MeSH terms:
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Antineoplastic Agents, Immunological
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Sargramostim
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents