A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
sabirnetug by intravenous infusion
sabirnetug + rHuPH20 by subcutaneous injection
Worldwide Clinical Trials
San Antonio, Texas, United States
Estimate blood levels of sabirnetug (ACU193)
Cmax (Maximum concentration, determined directly from individual concentration-time data)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach maximum blood levels of sabirnetug (ACU193)
Tmax (Time of the maximum concentration)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), terminal rate
λz (The observed terminal rate constant; estimated by linear regression through at least three data points in the terminal phase of the log concentration-time profile)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach half-life blood levels of sabirnetug (ACU193), half-life
T1/2 (The observed terminal half-life)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), concentration-time
AUC168h (Area under the concentration-time curve during a one-week dosing interval)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), last concentration-time
AUClast (Area under the concentration-time curve from time zero to the time of the last quantifiable concentration; calculated using the linear trapezoidal rule)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), infinity concentration-time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
AUCinf (Area under the concentration-time curve from time zero extrapolated to infinity)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), extrapolation
AUCExtrap (%)(The percentage of AUCinf based on extrapolation)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate blood levels of sabirnetug (ACU193), Clast
Clast (The last quantifiable concentration determined directly from individual concentration-time data)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50
Estimate time to reach last blood levels of sabirnetug (ACU193)
Tlast (Time of the last quantifiable concentration)
Time frame: Group 1: Day 1 (predose) up to Day 43 Group 2: Day 1 (predose) up to Day 50