Healthy Adult Subjects
Conditions
Keywords
Anti-GM-CSF agents, GM-CSF/GM-CSFR (GM-CSF receptor) antibody, colony-stimulating factor 2, monoclonal antibody
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).
Interventions
DRUGTJ003234
Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
DRUGPlacebo
Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
Sponsors
I-Mab Biopharma US Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Profile: AEs | Up to 85 days after study drug administration | Incidence of Adverse Events (AEs) |
| Maximum Tolerated Dose | Up to 85 days after study drug administration | Determine Maximum Tolerated Dose of TJ003234 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic (PK) Parameters: T1/2 | Up to 85 days after study drug administration | Investigational product (IP) half-life (T1/2) |
| Pharmacokinetic (PK) Parameters: CL | Up to 85 days after study drug administration | Investigational Product (IP) Clearance (CL) |
| Pharmacokinetic (PK) Parameters: Tmax | Up to 85 days after study drug administration | Time of peak concentration (Tmax) |
| Anti-drug antibodies (ADA) | Up to 85 days after study drug administration | Incidence and concentration of anti-drug antibodies |
| Pharmacokinetic (PK) Parameters: AUC∞ | Up to 85 days after study drug administration | Area under the curve from time zero extrapolated to infinity (AUC∞) |
| Pharmacokinetic (PK) Parameters: Cmax | Up to 85 days after study drug administration | Maximal Concentration (Cmax) |
Countries
United States
Outcome results
None listed