This is a Phase 1, first-in-human (FIH), randomized, double-blind, placebo-controlled, parallel-group, single ascending dose (SAD) study to evaluate the safety, tolerability, and pharmacokinetics of AH-008 administered as a single intravenous infusion in healthy adult subjects. Four sequential dose cohorts will be evaluated, each with sentinel dosing and SRC-reviewed dose escalation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
32
Lyophilized powder
Lyophilized powder
ICON Clinial Research Unit
Salt Lake City, Utah, United States
RECRUITINGIncidence of Treatment-Emergent Adverse Events (TEAEs)
Number of subjects experiencing one or more treatment-emergent adverse events, assessed according to MedDRA coding and investigator assessment.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Incidence of Clinically Significant Vital Sign Abnormalities
Number of subjects with clinically significant abnormalities in vital signs (blood pressure, heart rate, respiratory rate, and body temperature)
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Incidence of Clinically Significant 12-Lead ECG Abnormalities
Assessment includes PR interval, QRS duration, QT interval, QTcF interval, heart rate, rhythm.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Incidence of Clinically Significant Clinical Laboratory Abnormalities
Clinical laboratory assessments include hematology, serum chemistry and urinalysis parameters. Laboratory abnormalities will be evaluated by the investigator for clinical significance.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Incidence of Subjects with Infusion Site Reactions
Number and percentage of subjects experiencing infusion site reactions following administration of AH-008.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of AH-008
Maximum observed plasma concentration of AH-008 following a single intravenous administration.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of AH-008
Time to reach the maximum observed plasma concentration of AH-008 following a single intravenous administration.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of AH-008
Area under the plasma concentration-time curve of AH-008 following a single intravenous administration.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Pharmacokinetic characterization of terminal elimination half-life (t½) of AH-008
Terminal elimination half-life of AH-008 calculated from plasma concentration-time data following a single intravenous administration.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Pharmacokinetic characterization of cumulative amount of AH-008 excreted in urine (Ae0-t)
Based on individual urine concentration-time data collected using actual sampling times, the cumulative amount of unchanged AH-008 excreted in urine from time zero to the last measurable collection interval (Ae0-t) following a single intravenous administration will be determined.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)
Pharmacokinetic characterization of urine recovery rate of AH-008 (Ae%)
The percentage of administered AH-008 dose recovered unchanged in urine following a single intravenous administration will be determined.
Time frame: From Baseline (Day -1) through Day 3 (48 hours after dosing)