A randomized, double-blind, placebo-controlled, study to assess the safety, tolerability, and PK of MTX-463 when administered via SC injection in healthy adult males.
This is a randomized, double-blind, placebo-controlled, study to assess the safety, tolerability, and PK of MTX-463 when administered via SC injection in healthy adult males. The study will consist of a single cohort comprising 8 healthy male participants, who on Day 1 will be randomly assigned to receive MTX-463 or matched placebo. Randomization will be in a 3:1 ratio such that 6 participants will receive MTX-463 and 2 will receive placebo. Participants randomized to MTX-463 will receive a dose of 250 mg of MTX-463. Participants randomized to placebo will receive SC injections containing sodium chloride 0.9%. The injections will be given under the skin of the abdominal wall on Day 1. Blood will be drawn pre-dose on Day 1 for PK and antidrug antibodies (ADAs) and post-dose for PK at 6 and 24 hours. Participants will remain in the clinical research unit (CRU) for 24 hours after their injections, and then they will return for outpatient PK blood draws on Days 3 through 8, 15, and 22, with blood drawn for ADA assessment on Days 15 and 22. Each participant will undergo assessments at specified timepoints on Days 1 through 22 as detailed in Table 1. End-of-study procedures will be completed on Day 22 or upon early termination (ET). Local safety and tolerability at the injection site will be assessed at the time of the injections and for 24 hours afterward, and on Days 5, 8, 15 (±1 day), and 22 (±2 days) (EOS/ET).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
8
MTX-463 is an immunoglobin G1 (IgG1) monoclonal antibody directed against WNT-inducible signaling pathway protein 1 (WISP1). WISP1 (aka CCN-4) is a matricellular protein that appears to be upregulated locally in response to certain chronic diseases, including IPF, and malignancies.
Placebo
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Salt Lake City, Utah, United States
PK will be evaluated by area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
Time frame: 22 Days
PK will be evaluated by Maximum Observed Plasma Concentration (Cmax) of MTX-463
Unit of measure: ng/mL
Time frame: 22 Days
Comparisons of Maximum Observed Plasma Concentration (Cmax) of MTX-463 will be made to historical single-dose 4-mg/kg IV data.
Unit of measure: ng/mL
Time frame: 22 Days
Comparisons of area under the plasma concentration versus time curve from time zero to t (AUC0-t) of MTX-463 will be made to historical single-dose 4-mg/kg IV data.
Unit of Measure: Nanogram·hour per milliliter (ng·h/mL)
Time frame: 22 Days
Incidence of serious adverse events (SAEs)
Number SAEs as defined by protocol criteria
Time frame: 22 days
Incidence of Treatment Emergent Adverse Events (TEAEs)
Number of TEAEs summarized by seriousness and maximum severity as defined by protocol criteria
Time frame: 22 days
Incidence of Treatment Related Adverse Events (TRAEs)
Number of TRAEs summarized by seriousness and maximum severity as defined by Protocol criteria
Time frame: 22 days
Clinically significant findings on clinical laboratory tests
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Clinically significant findings in hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters will be summarized. Units of Measure: Standard laboratory units (e.g., g/dL, mEq/L, mg/dL, increase by factor)
Time frame: 22 days
Descriptive statistics on vital signs.
Descriptive statistics on temperature (Units: degrees Celcius), pulse rate (Units: beats per minute), respiratory rate (Units: breaths per minute), and blood pressure (Units: mmHg) will be assessed for change from Baseline, when applicable, and summarized by timepoint.
Time frame: 22 Days
Descriptive statistics on electrocardiograms (ECGs)
Descriptive statistics on ECG parameters (including but not limited to PR interval, QRS interval, QT, QTcF, and RR) will be assessed for change from Baseline, when applicable, and summarized by timepoint. Units: msec
Time frame: 22 Days
Descriptive statistics on clinical laboratory tests.
Descriptive statistics on hematology, clinical chemistry, urinalysis, and other protocol-specified laboratory parameters will be assessed for change from Baseline, when applicable, and summarized by timepoint. Units of Measure: Standard laboratory units (e.g., g/dL, mEq/L, mg/dL, increase by factor)
Time frame: 22 Days