This is a Phase 1, randomized, double-blind, placebo-controlled, multiple dose, dose escalation study in healthy participants, investigating the safety, tolerability, recovery, and PD of multiple oral administrations of SNIPR001.
Approximately 36 healthy male and female participants will be randomized to one of 3 active oral doses of SNIPR001 or matching placebo, administered twice a day (BID) for 7 days. Subjects will be followed up until 6 months after receiving the last dose of SNIPR001.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
36
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Safety and tolerability as measured by incidence and severity of AEs and Medically Attended Adverse Events (MAAEs) from the first administration of study drug and up until Day 35 of the study.
Time frame: 35 days
Incidence and severity of AEs and MAAEs from Day 35 to Day 187 of the study
Time frame: 152 days
Functional quantification of SNIPR001 (recovery) in feces, blood, and urine before, during, and after multiple oral SNIPR001 administrations
Time frame: 187 days
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