Healthy Volunteers Clinical Trial
Official title:
A Single Centre Study of Pharmacokinetics and Safety of NOX66 in Healthy Subjects
A Phase 1, double- blinded, randomised, placebo-controlled study to assess safety, tolerability and pharmacokinetics of 2 formulations of NOX66 in healthy subjects when administered over 4 cohorts as single NOX66 dose of 400 mg and 600 mg in comparison to single oral dose of 400 mg idronoxil.
The study will be a single-centre study of NOX66 in two formulations administered once
rectally and oral idronoxil . Approximately 50 subjects will be enrolled in 5 cohorts,
comprising 1 oral dose (400 mg) and 4 NOX66 dose Cohorts (400 and 600 mg in formulation A and
B).
Eligible subjects will be admitted to the research clinic the day prior to dosing for
baseline evaluations and will be fasted for a minimum of 10 hours prior to pre-dosing
procedures. On treatment day, subjects will be administered NOX66 suppository as single dose
or as oral suspension. Subjects remain in the clinic for 24 hours (h) after each dose for
safety and pharmacokinetic assessments and return for 3 follow up visits.
Ten subjects will be assigned to treatment dose Cohorts (1-5) and subjects within each of
these cohorts will be randomised to either active or placebo (n=8 active; n= 2 placebo).
For all dose cohorts, there will be two sentinel subjects (2 active) who will be dosed at a
minimum 24 hours prior to remainder of the cohort who will be dosed simultaneously
thereafter. Dose escalation of NOX66 dose cohorts to occur once safety and PK has been
confirmed, by Data Safety Monitoring Board, in subjects in the prior cohort as applicable.
Following interim review of accumulating PK data from first 3 cohorts, the Sponsor may modify
subject numbers within a cohort or cohort dose levels and implemented following approval by
IRB.
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