Clinical Trial: Phase 1 Safety Study of ALRN-5281 in Healthy Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Single-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety and Tolerability of ALRN-5281 Administered by Subcutaneous Injection in Healthy Adult Volunteers
Brief Summary: The primary objective of this study is to evaluate the safety and tolerability of a single dose of ALRN-5281 administered by subcutaneous injection to healthy adult volunteers.
Detailed Summary:
Sponsor: Aileron Therapeutics
Current Primary Outcome: Incidence of adverse events [ Time Frame: 28 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Serum IGF-1 [ Time Frame: Predose, Day 1-Day 28 ]
- Serum GH [ Time Frame: Predose, Day 1-Day 28 ]
- Time to Reach Maximum Observed Plasma Concentration (Tmax) of ALRN-5281 [ Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 ]
- Maximum plasma concentration (Cmax) of ALRN-5281 [ Time Frame: Predose, Day 1- 0.5,1,2,3,4,6,8,10,12,14 and 16hr post dose , Day 2-Day11 and Day14 ]
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Pre Dose, Day1- 0.5,1,2,3,4,6,8,10,12,14 and 16h post dose, Day2- Day11 and Day 14 ]AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Original Secondary Outcome: Same as current
Information By: Aileron Therapeutics
Dates:
Date Received: January 17, 2013
Date Started: January 2013
Date Completion:
Last Updated: May 29, 2013
Last Verified: May 2013