Clinical Trial: Trial to Evaluate Safety, Tolerability, and Parmacokinetics of ALN-TTR02 in Healthy Volunteer Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase 1, Randomized, Single-blind, Placebo-Controlled, Single Ascending Dose, Safety, Tolerability and Pharmacokinetics Study of ALN-TTR02 in Healthy Volunteers
Brief Summary: The purpose of this study is to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of a single dose of ALN-TTR02 in healthy volunteer subjects.
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation. [ Time Frame: Up to 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (PK) of ALN-TTR02 (Cmax, tmax, t1/2, AUC0-last, CL). [ Time Frame: Up to 180 days ]
- Effect of ALN-TTR02 on transthyretin (TTR), vitamin A, and retinol binding protein (RBP) (Determination of % Lowering of TTR, vitamin A and RBP to pretreatment/Baseline Levels) [ Time Frame: Up to 56 days ]
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: March 19, 2012
Date Started: March 2012
Date Completion:
Last Updated: January 14, 2013
Last Verified: January 2013
