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
Latest Information Update: 23 Aug 2024
At a glance
- Drugs Buprenorphine/naloxone (Primary) ; C4X 3256 (Primary)
- Indications Opioid-related disorders
- Focus Adverse reactions
- Sponsors Indivior
Most Recent Events
- 21 Aug 2024 Number of treatment arms has been changed from 5 to 9.
- 10 Jun 2024 According to an Indivior media release, completion of clinical Phase 1 Multiple Ascending Dose study happened after an end-of-Phase 1 meeting with the FDA on November 3, 2023, paving the way for the preparation and initiation of this clinical Phase 2 proof-of-concept (PoC) study.
- 01 Aug 2023 According to a C4X Discovery media release, the Phase 1 multiple ascending dose (MAD) study is currently ongoing.