The purpose of Parts D and E of this Phase 1 study are to evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants.
This is a Phase 1 randomized, double-blind, placebo-controlled study. Parts D and E will evaluate the safety, tolerability, and pharmacokinetics of multiple dose combinations of SION-451 and complementary modulators SION-2222 and SION-109 in healthy participants. Parts A, B, and C of this study have completed dosing. Part D will involve multiple dosing of SION-451 and SION-2222 in combination. Part E will involve multiple dosing of SION-451 and SION-109 in combination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Nucleus Network
Brisbane, Queensland, Australia
Nucleus Network
Melbourne, Victoria, Australia
To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-109 when administered in combination to healthy participants
Adverse reactions to the study drug combination SION-451 and SION-109 will be measured.
Time frame: From Day 1 through day 21
To evaluate the incidence of treatment emergent adverse events [Safety and Tolerability] of SION-451 and SION-2222 when administered in combination to healthy participants
Adverse events to the study drug combination SION-451 and SION-2222 will be measured
Time frame: From Day 1 through day 21
Cmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Tmax of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
AUC of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
t1/2 of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Volume of distribution of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Apparent total clearance of SION-451 and SION-2222 in plasma when administered in combination to healthy participants
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Placebo matched to SION-451
Placebo matched to SION-2222
Placebo matched to SION-109
Time frame: From Day 1 through day 17
Cmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Tmax of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
AUC of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
t1/2 of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Volume of distribution of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17
Apparent total clearance of SION-451 and SION-109 in plasma when administered in combination to healthy participants
Time frame: From Day 1 through day 17