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Completed

NCT Number: NCT03794180

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects

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).

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pharmaron

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TJ003234

Drug

Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline

Placebo

Drug

Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

I-Mab Biopharma US Limited

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 4, 2019
Registry last updated
Dec 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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