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