The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
S-892216-LAI injection will be administered per schedule specified in the arm description.
Physiological saline will be administered per schedule specified in the arm description.
ICON Clinical Research: Lenexa
Lenexa, Kansas, United States
RECRUITINGICON Clinical Research: Salt Lake City
Salt Lake City, Utah, United States
RECRUITINGPart: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 through Day 364
Part 2: Number of Participants With TEAEs
Time frame: Day 1 through Day 448
Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Cmax of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: Tmax of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 364
Part 2: AUC0-last of S-892216 and its Metabolites
Time frame: Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2
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