Clinical Trial: Phase 1 Safety Study of ALK-001 in Healthy Volunteers

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

Official Title: A Phase 1, Open Label, Repeat Dose Study to Investigate the Safety and Pharmacokinetics of 4-week Daily Dosing of ALK-001 in Healthy Volunteers

Brief Summary: This protocol is a phase 1 clinical study to assess the safety and pharmacokinetics of ALK-001 in healthy volunteers. Please contact [email protected] for any questions.

Detailed Summary:
Sponsor: Alkeus Pharmaceuticals, Inc.

Current Primary Outcome: Safety of 4-week daily dosing of ALK-001 in healthy adults. [ Time Frame: 4 weeks ]

Safety evaluations combine: adverse events (AE), laboratory testing (hematology and biochemistry panels), 12-lead electrocardiograms (ECGs), vital signs, physical examination, and visual function (visual acuity and a self-reported questionnaire).


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alkeus Pharmaceuticals, Inc.

Dates:
Date Received: August 27, 2014
Date Started: April 2014
Date Completion:
Last Updated: March 21, 2015
Last Verified: March 2015