A Study to Evaluate ALN-4285 in Adult Healthy Volunteers
Phase 1 – testing safety in a small group of people
Conditions:
Healthy Volunteers
Sponsor: Alnylam Pharmaceuticals
trial.available_in:
БГ
Overview
The purpose of this study is to:
* evaluate the safety and tolerability of single ascending doses of ALN-4285 in healthy volunteers
* characterize the single-dose pharmacokinetics (PK) of ALN-4285
Who can participate
Inclusion Criteria:
* Has a body mass index (BMI) of ≥18.0 kg/m\^2 and ≤30 kg/m\^2
* Has 12-lead ECG within normal limits or with no clinically significant abnormalities in the opinion of the Investigator
Exclusion Criteria:
* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>upper limit of normal (ULN)
* Has total bilirubin \>ULN
* Has systolic blood pressure \>140 mmHg and/or a diastolic blood pressure \>90 mmHg
* Has an estimated glomerular filtration (eGFR) of \<90 mL/min/1.73m\^2 at screening
* Has received an investigational agent within the last 30 days or 5 half-lives