The purpose of AROCFB-1001 is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARO-CFB Injection in adult healthy volunteers (HVs). HVs will receive either one or two doses of ARO-CFB or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
49
Research Site
Auckland, New Zealand
Number of Participants with Treatment-Emergent Adverse Events (AEs) and/or Serious Adverse Events (SAEs)
Time frame: up to Day 169 (End of Study [EOS])
Pharmacokinetics (PK) of ARO-CFB: Maximum Observed Plasma Concentration (Cmax)
Time frame: up to 48 hours postdose
PK of ARO-CFB: Time to Maximum Observed Plasma Concentration (Tmax)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to 24 Hours (AUC0-24)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero to the Last Quantifiable Plasma Concentration (AUClast)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Area Under the Plasma Concentration Versus Time Curve from Zero Extrapolated to Infinity (AUCinf)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Terminal Elimination Half-Life (t1/2)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Apparent Clearance (CL/F)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Volume of Distribution (Vz/F)
Time frame: up to 48 hours post-dose
PK of ARO-CFB: Amount of Drug Recovered in Urine Over Zero - 24 Hours Post-dose (Ae)
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Time frame: up to 24 hours post-dose
PK of ARO-CFB: Fraction of Drug Excreted Unchanged (fe)
Time frame: up to 24 hours post-dose
PK of ARO-CFB: Renal Clearance (CLr)
Time frame: up to 24 hours post-dose