A Study to Assess the Safety and Tolerability of PUR 0110 Rectal Enema in Normal Healthy Volunteers
Status:
Completed
Trial end date:
2009-08-01
Target enrollment:
Participant gender:
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.