Clinical Trial: Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects

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

Official Title: A Randomized, Double-blind, Placebo-controlled, Ascending Dose, Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Intravenous and Subcutaneous Doses of Recombinant Human

Brief Summary: This trial is looking to gain information about the safety and tolerability of an investigational treatment (SHP623) in healthy adult volunteers. This study will also collect pharmacokinetic data (how the body absorbs and breaks down the study drug).

Detailed Summary:
Sponsor: Shire

Current Primary Outcome: Number of participants with treatment-emergent adverse events (TEAEs ) including SAEs [ Time Frame: Day -1 to day 28 per treatment period ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum concentration occurring at tmax (Cmax) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Time to reach the maximum plasma concentration (Tmax) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Terminal half-life (t ½) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the plasma concentration curve from time zero to 168 hours postdose of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the curve from the time of dosing to the last measurable concentration (AUClast) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Total body clearance for intravascular administration (CL) of IV SHP623 [ Time Frame: Predose up to 648 hours ]
  • Volume of distribution associated with the terminal slope (Vz) following IV administration of SHP623 [ Time Frame: Predose up to 648 hours ]
  • Maximum concentration occurring at tmax (Cmax) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Time to reach the maximum plasma concentration (Tmax) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Terminal half-life (t ½) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the plasma concentration curve from time zero to infinity (AUC0-∞) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the plasma concentration curve from time zero to 168 hours postdose of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Area under the curve from the time of dosing to the last measurable concentration (AUClast) of SC SHP623 [ Time Frame: Predose up to 648 hours ]
  • Total body clearance for extravascular administration divided by the fraction of dose absorbed CL/F (SC) of SC SHP623 adult [ Time Frame: Predose up to 648 hours ]
  • Volume of distribution associated with the terminal slope following extravascular administration (Vz/F)divided by the fraction of dose absorbed of SHP623 [ Time Frame: Predose up to 648 hours ]


Original Secondary Outcome: Same as current

Information By: Shire

Dates:
Date Received: December 21, 2015
Date Started: April 2016
Date Completion:
Last Updated: December 9, 2016
Last Verified: December 2016