Healthy Volunteer Clinical Trial
Official title:
A Phase I Double-Blind, Placebo-Controlled Randomized Study to Assess Repeated Doses of INDV-2000 (C4X_3256) up to 28 Days in Healthy Volunteers, and an Open-Label Study of INDV-2000 up to 11 Days in Treatment Seeking Individuals With Opioid Use Disorder
The primary objectives for the study are: - Part I and Part II: Assess safety and tolerability of repeated doses of INDV-2000 in healthy volunteers. - Part III: Assess the safety and tolerability of repeated doses of INDV-2000 administered alone and with SUBOXONE sublingual (SL) film in an opioid use disorder (OUD) treatment seeking population.
The study will be conducted in 3 parts: Part I: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 7 days of dosing with INDV-2000 in healthy volunteers. Part II: Double-blind, placebo-controlled, randomized, multiple ascending dose study for 28 days of dosing with INDV-2000 in healthy volunteers. Part III: This part is an open-label study in OUD treatment seeking individuals. ;
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