The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-TTRSC02 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
Ascending doses of ALN-TTRSC02 by subcutaneous (SC) injection
Calculated volume to match active comparator
Clinical Trial Site
London, United Kingdom
Safety of ALN-TTRSC02, evaluated by the proportion of subjects experiencing adverse events (AEs)
Time frame: Day 1 through to Day 314
Profile of pharmacokinetics (PK) of ALN-TTRSC02
Cmax
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
tmax
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
AUC
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
t½
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
CL/F
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
Vss/F
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
Vz/F
Time frame: Day 1 through to Day 3
Profile of pharmacokinetics (PK) of ALN-TTRSC02
fe
Time frame: Day 1 through to Day 314
Profile of pharmacokinetics (PK) of ALN-TTRSC02
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CLR
Time frame: Day 1 through to Day 314
Effect of ALN-TTRSC02 on serum TTR levels as measured by reduction from baseline in serum TTR
Time frame: Day 1 through to Day 314
Effect of ALN-TTRSC02 on serum Vitamin A levels as measured by reduction from baseline in serum Vitamin A
Time frame: Screening through to Day 314