Randomized, placebo-controlled, modified parallel-design single ascending dose (SAD) in adult healthy volunteers (HVs).
Study NTRX-07-C101 will be conducted with a modified parallel design, incorporating sentinel subjects and a staggered-dosing-days approach. Up to 6 cohorts, A-F, are planned for a total of 48 completing subjects. Each dose cohort will be randomized with 6 subjects receiving active drug and 2 placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
48
NTRX-07-SDD for oral administration
Orange County Research Center
Tustin, California, United States
Number of subjects with treatment emergent adverse events of NTRX-07
Reported Treatment related Adverse Events
Time frame: Seven days
Number of subjects with Treatment related subjective effects of NTRX-07
Reported Treatment related subjective effects Events
Time frame: Seven days
Plasma levels of NTRX-07
Plasma levels of NTRX-07
Time frame: 24 hours
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