RE: Phase 1a trial9 Aug 2023 09:36
From the 6th June RNS - "The phase 1a trial includes a single ascending dose study (Part 1), a multiple ascending dose study (Part 2) and a food effects study (Part 3). Part 1 will consist of at least 6 sequential, ascending dose cohorts of 8 subjects each (total of 48 subjects) randomised to receive SDC-1801 or matched placebo in a 3:1 ratio. Each subject will be in Part 1 for approximately 6 weeks (screening visit to follow-up visit). Part 2 (multiple ascending dose) is planned to commence after the Safety Review Committee (SRC) has evaluated the available data from at least Cohorts A, B, and C in Part 1.
The multiple ascending dose part of the trial will consist of at least 4 sequential, ascending doses of SDC-1801 or matched placebo cohorts (cohorts A to D). Each cohort in Part 2 will consist of 8 subjects (a total of 32 subjects). Each subject will be in the study for approximately 8 weeks. Part 3 of the study is expected to run in parallel with Part 2, and will examine how food affects the absorption of SDC-1801.
The Company expects to provide a further update on the trial once initial safety and pharmacokinetic data observed in the single ascending dose study provide sufficient support for progression to Part 2 of the study, expected in H2 2023."
The full safety data for the above P1a trial is expected to be available in H1 2024. The P1b trial for psoriasis will start shortly after.