Clinical Trial: A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Phase 1/2 Single-ascending and Multiple-ascending Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-CC5 in Healthy Adult Volunteers and Pati
Brief Summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ALN-CC5 in healthy adult volunteers and subjects with PNH
Detailed Summary:
Sponsor: Alnylam Pharmaceuticals
Current Primary Outcome: The safety of ALN-CC5 evaluated by the proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs), and AEs leading to study drug discontinuation [ Time Frame: Part A: through day 70; Part B: through day 140; Part C: through day 140 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Profile of Pharmacokinetics (PK) of ALN-CC5 [ Time Frame: Part A: up to 56 days; Part B: up to 56, days; Part C: up to 85 days ]Cmax, tmax, Area Under Curve, t1/2
- The effect of ALN-CC5 on serum levels of complement activity [ Time Frame: Part A: through day 70; Part B: through day 140; Part C through day 140 ]
- The effect of ALN-CC5 on serum levels of C5 protein [ Time Frame: Part A: through day 70; Part B: through day 140; Part C through day 140 ]
Original Secondary Outcome: Same as current
Information By: Alnylam Pharmaceuticals
Dates:
Date Received: January 23, 2015
Date Started: January 2015
Date Completion: December 2016
Last Updated: May 24, 2016
Last Verified: May 2016
