Clinical Trial: sPIF CLINICAL STUDY PROTOCOL FOR AUTOIMMUNE HEPATITIS

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

Official Title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability and Pharmacokinetics of Synthetic PreImplantation Factor (sPIF

Brief Summary: The purpose of this study is to study the safety and tolerability of synthetic PreImplantation Factor (sPIF) in female patients with autoimmune hepatitis. Autoimmune hepatitis is a disease where the patient's immune system produces an inappropriate immune response against their own liver. PreImplantation Factor is a substance that is secreted by viable fetuses during pregnancy. PIF apparently initiates both maternal tolerance preventing the loss/rejection of the fetus. Synthetic PIF (sPIF) successfully translates PIF endogenous properties to pregnant and non-pregnant immune disorders. sPIF was found to be effective in preclinical models of autoimmunity and transplantation (published). Specifically sPIF protected the liver against immune attack. In FDA mandated toxicity studies (mice, dogs), high-dose sPIF administration for 2 weeks followed by 2 weeks observation period demonstrated a high safety profile. Based on those observations the FDA has granted a Fast Track designation for this trial. This study will evaluate the safety, tolerability and the blood level of this synthetic version of this natural compound in the circulation.

Detailed Summary:
Sponsor: Christopher O'Brien

Current Primary Outcome: Safety [ Time Frame: 28 Day ]

Safety and tolerability will be evaluated by assessment of clinical laboratory tests, periodic physical examination, including vital signs measurements, and 12-lead ECG at baseline (pre-dose, Day 1) and at various time points during the treatment phases of both SAD and the MAD portions of the protocol, and by the documentation of adverse events. Concomitant medication intake will also be recorded.


Original Primary Outcome: Same as current

Current Secondary Outcome: Pharmacokinetics [ Time Frame: 28 Day ]

sPIF levels in the plasma will be determined at baseline, 30 (±5), 60 (±10) and 120 (±15) and 240 (±20) minutes after SQ injection using validated LC-MS/MS assay in both the SAD and MAD portions of the protocol.


Original Secondary Outcome: Same as current

Information By: University of Miami

Dates:
Date Received: September 10, 2014
Date Started: August 2014
Date Completion:
Last Updated: April 25, 2017
Last Verified: April 2017