Healthy Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Single and Multiple Doses of Orally Administered RDN-929 in Healthy Adult and Elderly Subjects
A three (3) part study to evaluate the safety, tolerability and PK of RDN-929
Part 1 (Randomized, Double Blind):
Up to 6 single ascending doses of RDN-929 are planned to be tested in 6 cohorts of 8 healthy
males (Cohort 1:1 to 1:6). Within each cohort subjects will be randomly assigned to receive
either a single dose of RDN-929 (6 subjects) or matched placebo (2 subjects).
Part 2 (Open):
Part 2 will consist of 2 crossover treatment periods in one cohort of 12 healthy elderly
subjects (at least 3 of each gender), aged 55-80 years. The treatments will be separated by a
washout period of at least 7 days. The dose selected for this part of the study will be based
on the results of Part 1.
In Period 1, subjects will be randomized to receive a single dose of RDN-929 in either fasted
or fed status. In Period 2, subjects will receive a single dose of RDN-929 under the
alternate status.
Part 3 (Randomized, Double Blind):
Multiple ascending doses (MAD) of RDN-929 are planned to be tested in up to 4 cohorts of 8
healthy elderly subjects (at least 3 of each gender per dose level cohort), aged 55-80 years.
The doses will be selected by the safety review committee (SRC) based on all available
safety, tolerability and PK data and after approval by the ethics committee.
Within each cohort subjects will be randomly assigned to receive either, RDN-929 once daily
(6 subjects) or matched placebo (2 subjects) once daily for 12 days. Escalation to the next
higher dose level will be based upon a review of the safety and tolerability data.
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