The primary purpose of the study is to evaluate the safety and tolerability of single intravenous (IV) infusions of E2025 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
32
Worldwide Clinical Trials
San Antonio, Texas, United States
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Screening up to Day 113
Number of Participants With Clinically Significant Abnormal Laboratory Values
Time frame: Screening up to Day 113
Number of Participants With Clinically Significant Abnormal Vital Signs Values
Time frame: Screening up to Day 113
Number of Participants With Clinically Significant Abnormal Electrocardiograms (ECGs) Findings
Time frame: Screening up to Day 113
Number of Participants With Clinically Significant Abnormal Physical Examinations Findings
Time frame: Screening up to Day 113
Number of Participants With Clinically Significant Abnormal Psychiatric Examination Findings
Time frame: Screening up to Day 8
Cmax: Maximum Observed Serum Concentration for E2025
Time frame: Day 1: 0-24 hours up to Day 113
Tmax: Time to Reach Maximum Observed Serum Concentration (Cmax) for E2025
Time frame: Day 1: 0-24 hours up to Day 113
AUC(0-t): Area Under the Serum Concentration-time Curve From Time Zero to Last Quantifiable Concentration for E2025
Time frame: Day 1: 0-24 hours up to Day 113
AUC(0-inf): Area Under the Serum Concentration-time Curve From Time Zero to Infinite for E2025
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 1: 0-24 hours up to Day 113
AUC(0-24h): Area Under the Serum Concentration-time Curve From Time Zero to 24 hours for E2025
Time frame: Day 1: 0-24 hours
AUC(0-72h): Area Under the Serum Concentration-time Curve From Time Zero to 72 hours for E2025
Time frame: Day 1: 0-72 hours
AUC(0-672h): Area Under the Serum Concentration-time Curve From Time Zero to 672 hours for E2025
Time frame: Day 1: 0-672 hours
t1/2: Terminal Elimination Phase Half-life for E2025
Time frame: Day 1: 0-24 hours up to Day 113
CL/F: Apparent Total Clearance for E2025
Time frame: Day 1: 0-24 hours up to Day 113
Vss: Volume of Distribution at Steady State for E2025
Time frame: Day 1: 0-24 hours up to Day 113
Part A: Cerebrospinal Fluid (CSF) Concentrations for E2025
Time frame: Pre-dose; Days 8 and 29 post-dose
Part B, CSF Cmax: Maximum Observed CSF Concentration for E2025
Time frame: Day 1: 0-24 hours up to Day 99
Part B, CSF Tmax: Time to Reach Maximum Observed CSF Concentration (Cmax) for E2025
Time frame: Day 1: 0-24 hours up to Day 99
Part B, CSF AUC(0-24h): Area Under the CSF Concentration-time Curve From Time Zero to 24 hours for E2025
Time frame: Day 1: 0-24 hours
Part B: Ratio of Cmax in CSF and Cmax in Serum for E2025
Time frame: Day 1: 0-24 hours up to Day 99
Part B: Ratio of AUC(0-24h) in CSF and AUC(0-24h) in Serum for E2025
Time frame: Day 1: 0-24 hours
Serum Concentration of Anti- E2025 Antibodies
Time frame: Day 1 up to Day 113