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

NCT03794180 | Completed Phase 1 FDA Drug

• 1 other identifier: TJ003234RAR101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Healthy Adult Subjects

Keywords

Anti-GM-CSF agents; GM-CSF/GM-CSFR (GM-CSF receptor) antibody; colony-stimulating factor 2; monoclonal antibody

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pharmacokinetic (PK) Parameters: Tmax

  Up to 85 days after study drug administration

• Pharmacokinetic (PK) Parameters: Cmax

  Up to 85 days after study drug administration

• Pharmacokinetic (PK) Parameters: T1/2

  Up to 85 days after study drug administration

• Pharmacokinetic (PK) Parameters: CL

  Up to 85 days after study drug administration

• Pharmacokinetic (PK) Parameters: AUC∞

  Up to 85 days after study drug administration

Study Arms (2)

TJ003234

EXPERIMENTAL

0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion

Drug: TJ003234

Placebo

PLACEBO COMPARATOR

0 mg/kg via single IV infusion

Drug: Placebo

Interventions

TJ003234 DRUG

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

TJ003234

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• I-Mab Biopharma US Limited: lead

Study Sites (1)

Pharmaron

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

plonmarlimab

Study Officials

• Claire Xu, MD, PhD

  I-Mab Biopharma

  STUDY DIRECTOR

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: December 28, 2018
• First Posted: January 4, 2019
• Study Start: March 18, 2019
• Primary Completion: September 5, 2019
• Study Completion: September 5, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)