The primary objective of this study is to evaluate the safety and tolerability of single and multiple intravenous infusions of E2814 in healthy adult participants.
The study is comprised of two components: a single ascending dose (SAD) component and a multiple ascending dose (MAD) component. The SAD component consists of 5 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive a single dose of E2814 or E2814-matched placebo. The MAD component of the study consists of 4 sequential cohorts and in each cohort, 8 healthy participants are randomized (3:1) to receive E2814 or E2814-matched placebo every 4 weeks (Q4W) on 3 occasions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
72
E2814, intravenous infusion.
E2814-matched placebo, intravenous infusion.
California Clinical Trials Medical Group/Parexel International
Glendale, California, United States
Worldwide Clinical Trials
San Antonio, Texas, United States
SAD, Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Vital Signs Values
Time frame: Up to 113 days
SAD, Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Time frame: Up to 113 days
MAD, Number of Participants With TEAEs and SAEs
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant Laboratory Values
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant Vital Signs Values
Time frame: Up to 169 days
MAD, Number of Participants With Clinically Significant ECG Findings
Time frame: Up to 169 days
SAD, Cmax Serum: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
SAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Serum: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Serum: Terminal Elimination Phase Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Serum: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Serum: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Serum anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Cmax CSF: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, Tmax CSF: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 29 Post Dose
SAD, AUC (0-24h) CSF: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, Cmax Plasma: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
SAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
SAD, AUC (0-inf) Plasma: Area Under the Concentration-time Curve from Time 0 to Infinity for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, t½ Plasma: Terminal Elimination Phase Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, CL Plasma: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Vz Plasma: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
SAD, Plasma anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 113 Post Dose
MAD, Cmax Serum: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Serum: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Serum: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Serum: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Serum: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Serum: Terminal Elimination Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Serum: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Vz Serum: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(Cmax) Serum: Ratio of Accumulation for Cmax for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(AUC) Serum: Ratio of Accumulation for AUC for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Serum anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CSF Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 85 Post Dose
MAD, Cmax Plasma: Maximum Observed Concentration for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Tmax Plasma: Time to Reach the Maximum Observed Concentration (Cmax) for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, AUC (0-24h) Plasma: Area Under the Concentration-time Curve From Time Zero to 24 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 24 hours Post Dose
MAD, AUC (0-72h) Plasma: Area Under the Concentration-time Curve From Time Zero to 72 Hour for E2814
Time frame: Pre-dose (Day 1) and up to 72 hours Post Dose
MAD, AUC (0-tau) Plasma: Area Under the Concentration-time Curve From Zero Time to the end of the Dosing Interval for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, t½ Plasma: Terminal Elimination Half-life for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, CL Plasma: Clearance for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Vz Plasma: Volume of Distribution for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(Cmax) Plasma: Ratio of Accumulation for Cmax for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Rac(AUC) Plasma: Ratio of Accumulation for AUC for E2814
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose
MAD, Plasma anti-E2814 Antibody Concentration
Time frame: Pre-dose (Day 1) and up to Day 169 Post Dose