A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers

Ulcerative Colitis Clinical Trial

Official title: A Randomized, Double-Blind, Parallel-Group, Single-Ascending Dose, Placebo-Controlled Safety and Tolerability Study of PUR 0110 Rectal Enema in Normal Healthy Volunteers

Status Completed

Clinical Trial Summary

This is a first-in-man study of a novel investigational botanical drug complex, PUR 0110 rectal enema, that has been shown to have potent anti-inflammatory, antioxidant and immunomodulatory effects following in vitro and in vivo pharmacology studies, to assess the safety and tolerability of sequential single-ascending doses in normal healthy volunteers and to determine the maximum tolerated dose (MTD). As a tertiary objective, the study will also investigate the presence of specific pharmacokinetic markers following the administration of single-dose PUR 0110 at each dose level.

The study is designed as a single-center, randomized, double-blind, parallel-group, sequential single-ascending dose, placebo-controlled safety, tolerability and pharmacokinetic study of PUR 0110 rectal enema in 24 normal healthy male volunteers. Eligible subjects will be randomly assigned to 4 Cohorts of 6 subjects each to receive active drug (PUR 0110 Enema) or placebo enema as follows: 187.5 mg/60 g - Cohort 1, 375 mg/60 g - Cohort 2, 750 mg/60 g - Cohort 3 or 1500 mg/60 g - Cohort 4. Within each Cohort, subjects will be randomized in a 2:1 ratio to receive either active treatment (PUR 0110 enema; n = 4) or placebo enema (n = 2). Each subject will receive only 1 dose of assigned study medication and dosing of subjects within each cohort will also be by sequential inclusion.

Clinical Trial Description

Flexible sigmoidoscopy will be performed during the Screening Period within 72 to 48 hours pre-dose and within 9 +/- 1 hours post-dosing to visually examine the colonic mucosa for any signs of local toxicity and grade it as normal/abnormal; and 3 pinch biopsies will be obtained at each endoscopy at about the same level in the colon (<50 cm from the anal verge) for histology. At the baseline flexible sigmoidoscopy, subjects must have normal colonic and rectal mucosa (i.e., no bleeding, inflammation, edema, ulceration or other abnormal finding) to be included in the study. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

• NCT number: NCT01149694
• Study type: Interventional
• Source: PurGenesis Technologies Inc.
• Status: Completed
• Phase: Phase 1
• Start date: June 2009
• Completion date: August 2009