This randomized, double-blind, placebo controlled, study will be conducted to evaluate the safety, tolerability, and pharmacokinetics of ST-2427. Subjects will be randomized to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. A total of 30 subjects will be enrolled. Subjects will be randomized in a 4:2 ratio of ST-2427 to placebo. Study drug will be blinded to all subjects and investigators.
This is a Phase 1, randomized, double-blind, placebo-controlled study in healthy adult males and females of non-child-bearing potential to evaluate the safety, tolerability, and pharmacokinetics (PK) of ST-2427. This trial will include careful assessments of treatment effects on vital signs including cardiac and respiratory function and body temperature over a range of doses of ST-2427, administered as single doses. SiteOne Therapeutics, Inc. plans to use the safety, tolerability, and PK findings from this study to inform the doses and study design for Phase 2 clinical studies in subjects with acute post-operative pain. Approximately 30 subjects, 6 subjects into each of 5 cohorts, will be enrolled in this study at a single clinical site. Subjects will be randomized 4:2 to receive a single dose of ST-2427 or placebo in a Single Ascending Dose (SAD) design. The Study will evaluate 5 dose strengths of ST-2427, one dose level in each of 5 cohorts of subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Altasciences
Overland Park, Kansas, United States
Number of Participants With Treatment-emergent Adverse Events
For purposes of monitoring safety, treatment-emergent adverse events (AEs) will be graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers (FDA 2007) which is appropriate for healthy subjects.
Time frame: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by Blood Pressure
Blood pressure, including orthostatic blood pressure (BP; diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\]), will be used to analyze for change from baseline. Adverse events assessed by blood pressure include hypertension and hypotension (MedDRA Preferred Term).
Time frame: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by ECG
Cardiodynamic evaluation will be performed to evaluate the treatment effects on heart rate-corrected QT interval using the Fridericia (QTcF) corrections.
Time frame: Day 1 through Day 8
Number of Participants With Treatment-emergent Events Assessed by Clinical Laboratory Assessments
Descriptive statistics will be used to evaluate the treatment effects on clinical laboratory assessments including clinical chemistry, hematology, and urinalysis.
Time frame: Day 1 through Day 8
Number of Participants With Adverse Events Assessed by Body Weight
Body weight (kg) will be assessed for changes relative to baseline.
Time frame: Day 1 through Day 8
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Cmax
PK modeling will be performed using compartmental methods. The maximum concentration of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
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Time frame: 0-48 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Time frame: 0-9 hours
Pharmacokinetics of ST-2427 Concentration in Whole Blood: Area Under the Curve
PK modeling will be performed using compartmental methods. The AUC (area under the curve) of ST-2427 in whole blood after the ST-2427 infusion in the SAD.
Time frame: 0-25 hours