The purpose of this study is to evaluate the safety and tolerability of single and multiple doses of the antisense inhibitor ION547 administered subcutaneously (SC) in healthy participants.
This is a Phase 1, double-blind, randomized, placebo-controlled, dose escalation study of ION547 in up to 76 participants. Participants will be randomized to receive single and multiple doses of ION547 or placebo SC. The maximum length of participation in the study will be approximately 34 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
BioPharma Services, Inc.
Toronto, Ontario, Canada
Number of Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Up to Day 232
Cmax: Maximum Observed Plasma Concentration of ION547
Time frame: Up to Day 232
Tmax: Time Taken to Reach Maximal Plasma Concentration of ION547
Time frame: Up to Day 232
AUCt: Area Under the Plasma Concentration-time Curve From Time Zero to Time t for ION547
Time frame: Up to Day 232
Urine 0-24 Hour (hr) Excretion of ION547
Time frame: Up to 24 hours
Change from Baseline in FXII Antigen Levels
Time frame: Up to Day 232
Change from Baseline in FXII Activity Levels
Time frame: Up to Day 232
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