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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Adult Subjects
• Intervention / Treatment: Drug: TJ003234; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Pharmaron

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile: AEs	Incidence of Adverse Events (AEs)	Up to 85 days after study drug administration
Maximum Tolerated Dose	Determine Maximum Tolerated Dose of TJ003234	Up to 85 days after study drug administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetic (PK) Parameters: Tmax	Time of peak concentration (Tmax)	Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: Cmax	Maximal Concentration (Cmax)	Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: T1/2	Investigational product (IP) half-life (T1/2)	Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: CL	Investigational Product (IP) Clearance (CL)	Up to 85 days after study drug administration
Pharmacokinetic (PK) Parameters: AUC∞	Area under the curve from time zero extrapolated to infinity (AUC∞)	Up to 85 days after study drug administration
Anti-drug antibodies (ADA)	Incidence and concentration of anti-drug antibodies	Up to 85 days after study drug administration

Collaborators and Investigators

• Sponsor: I-Mab Biopharma Co. Ltd.
• Investigators: Study Director: Claire Xu, MD, PhD, I-Mab Biopharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 18, 2019
• Primary Completion (ACTUAL): September 5, 2019
• Study Completion (ACTUAL): September 5, 2019

Study Registration Dates

• First Submitted: December 28, 2018
• First Submitted That Met QC Criteria: January 2, 2019
• First Posted (ACTUAL): January 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 16, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: monoclonal antibody; Anti-GM-CSF agents; GM-CSF/GM-CSFR (GM-CSF receptor) antibody; colony-stimulating factor 2
• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Anti-Inflammatory Agents; Plonmarlimab
• Other Study ID Numbers: TJ003234RAR101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No