Healthy Volunteers
Conditions
Keywords
RNAi therapeutic
Brief summary
The purpose of this study is to evaluate the safety, tolerability and PK of single ascending doses of ALN-AGT01 RVR.
Interventions
DRUGALN-AGT01 RVR
ALN-AGT01 RVR will be administered subcutaneously (SC)
DRUGPlacebo
Placebo will be administered SC
Sponsors
Alnylam Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Is an adult healthy volunteer * Has a body mass index ≥18 kg/m\^2 and ≤28 kg/m\^2
Exclusion criteria
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> upper limit of normal (ULN) * Has known human immunodeficiency virus infection; or known current or chronic hepatitis C virus or hepatitis B virus infection * Has an estimated glomerular filtration rate (eGFR) of \<90 mL/min/1.73m\^2 at screening Note: other protocol defined inclusion /
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events (AEs) | Up to 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) of ALN-AGT01 RVR in Plasma | Predose and up to 3 days postdose | — |
| Maximum Observed Plasma Concentration (Cmax) of ALN-AGT01 RVR in Plasma | Predose and up to 3 days postdose | — |
| Time to Maximum Plasma Concentration (Tmax) of ALN-AGT01 RVR in Plasma | Predose and up to 3 days postdose | — |
| Concentrations of ALN-AGT01 RVR in Urine | Predose and up to 1 day postdone | Fraction of ALN-AGT01 RVR excreted in urine |
Countries
Canada
Outcome results
None listed