HUGE NEWS FOR ICO Phase 1 Oral Amp B Clinical Trial
The Phase 1 Australian study is a randomized, double-masked, placebo-controlled, single dose ascending study to assess the safety, tolerability, and bioavailability of iCo-019 (Oral Amphotericin B). Subjects were randomized into one of 4 cohorts dosed sequentially at 100 mg, 200 mg, 400 mg and 800 mg. Each cohort consisted of eight (8) subjects where six (6) subjects were randomized to receive the Investigational Product (IP) and two (2) subjects were randomized to receive Placebo.
The safety profile for each subject dosed in each of the first three cohorts was reviewed by the Safety Review Committee (SRC) before proceeding to a higher dose. With the conclusion of recruitment, safety will be assessed for all subjects in addition to pharmacokinetic profiles.
Amphotericin B is an approved drug for the treatment of fungal and parasitic conditions but the current leading formulation is an intravenous infusion. iCo Therapeutics is developing a proprietary oral formulation to increase convenience and market application.
We currently expect results from the Phase 1 study in early July 2018.
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