Determine the safety, tolerability and pharmacokinetics of single doses of ARCT-810 in healthy adult subjects.
This is a single ascending dose study of ARCT-810 in which approximately 30 subjects are planned to be enrolled. The length of each study participant is approximately 8 weeks from screening to last study visit. Study participants will be allocated to one of the five different study groups (also called cohorts), to test different doses of ARCT-810. There will be 6 participants in each group. Within each cohort, subjects will be randomized 2:1 to receive ARCT-810 or placebo as an IV infusion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Auckland Clinical Studies (ACS) Ltd.
Auckland, New Zealand
Incidence, severity and dose-relationship of AEs
Safety and tolerability of ARCT-810 assessed by determining the incidence, severity and dose-relationship of AEs by dose
Time frame: 4 weeks
Number of participants with changes in plasma pharmacokinetic parameters after single dose of ARCT-810
The plasma pharmacokinetics (concentration-time results) of ARCT-810 will be assessed following single dose
Time frame: Up to 15 days
Number of participants with changes in urine pharmacokinetic parameters after single dose of ARCT-810
The urine pharmacokinetics (concentration-time results) of ARCT-810 will be assessed following single dose
Time frame: Up to 24 hours
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