This is a single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects.
The study plans to enroll up to 28 subjects. Its primary purpose is to conduct a preliminary assessment of the exposure, safety, and pharmacokinetic profile of EA5 in humans, thereby informing the confirmation or adjustment of the formal trial design. The trial is structured into a pilot phase and a formal phase, encompassing a total of five planned dose cohorts: the pilot trial involves two dose groups (90 mg and 180 mg), each with 2 subjects receiving the active drug; the formal trial consists of three dose groups (360 mg, 720 mg, and 1440 mg), where participants are randomized in a 3:1 ratio (6 subjects receiving the active drug EA5 and 2 subjects receiving placebo per cohort), administered via intravenous (IV) infusion.A 57-day observation period was performed for safety, pharmacokinetic, and pharmacodynamic assessments after study drug administration. Antidrug antibody (ADA) levels were monitored in study participants for the duration of the 57-day follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
28
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
TEAEs were defined as AEs that occurred on or after the date and time of study drug administration, or those that first occurred before dosing but worsened in frequency or severity after study drug administration. A summary of all Serious Adverse Events and Other Adverse Events (nonserious) regardless of causality is located in the 'Reported Adverse Events' Section.
Time frame: Baseline up to Day 57
Maximum Observed Serum Concentration (Cmax) of EA5
Blood samples were collected for analysis of Cmax
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Time To Maximum Observed Serum Concentration (Tmax) of EA5
Blood samples were collected for analysis of Tmax
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Area Under The Serum Concentration Versus Time Curve From Time Zero To The Time of The Last Quantifiable Concentration (AUC0-t) of EA5
Blood samples were collected for analysis of AUC0-t
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Area Under The Serum Concentration Versus Time Curve From Time Zero (Dosing) To Infinity (AUCinf) of EA5
Blood samples were collected for analysis of AUCinf
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Rate Constant (λz) of Serum EA5
Blood samples were collected for analysis of λz
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Terminal Elimination Half-life (t½) of Serum EA5
Blood samples were collected for analysis of t½
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Total Clearance (CL) of EA5
Blood samples were collected for analysis of CL
Time frame: 30 minutes predose, 5 minutes, 1, 2, 6, 24, hours postdose, then at Days 3, 4, 8, 15, 29, 43, 57
Percent Change From Baseline in Free Complement Component 5 (C5)
Blood samples were collected for analysis of free C5 concentrations.
Time frame: Baseline, Day 57
Percent Change From Baseline in Total Complement C5
Blood samples were collected for analysis of total C5 concentrations.
Time frame: Baseline, Day 57
Percent Change From Baseline in determination of terminal complement activity in serum
Blood samples were collected for analysis of determination of terminal complement activity
Time frame: Baseline, Day 57
Percentage of Participants With Positive Anti-Drug Antibody (ADA)
lood samples were collected to evaluate antibody response through development of ADAs.
Time frame: Baseline up to Day 57