Clinical Trial: Phase 1 Single Dose Study of ALXN1101 in Healthy Volunteers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Phase 1, Randomized, Blinded, Placebo-Controlled, Single-Dose, Sequential-Cohort, Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ALXN1101 in Healthy Adult Subject

Brief Summary: Phase 1 single dose study of ALXN1101 in healthy volunteers.

Detailed Summary: This is a first-in-human (FIH), randomized, blinded, placebo-controlled, single-dose, sequential-cohort, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a single dose of ALXN1101 in healthy adult subjects.
Sponsor: Alexion Pharma GmbH

Current Primary Outcome: Safety and tolerability of single dose of ALXN1101 in healthy adult subjects [ Time Frame: following the Day 30 visit for the last study subject ]

Physical examination, vital signs, ECGs, laboratory evaluations, and Adverse Events.


Original Primary Outcome: Same as current

Current Secondary Outcome: PK parameters of ALXN1101 [ Time Frame: following the Day 5 visit for the last study subject ]

PK parameters of ALXN1101 will be estimated including, but not limited to,maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (tmax), terminal elimination halflife (t½), area under the plasma concentration-time curve (AUC), total body clearance (CL), and volume of distribution (Vd).


Original Secondary Outcome: Same as current

Information By: Alexion Pharma GmbH

Dates:
Date Received: June 27, 2013
Date Started: June 2013
Date Completion:
Last Updated: November 5, 2013
Last Verified: November 2013