drugset / Trial / NCT04122755
Single Ascending Dose Study of ALA-1000
Non-randomizedParallel-groupOpen-labelTreatment
Summary
An open-label study designed to evaluate the safety, tolerability, and pharmacokinetics of ALA-1000 in opioid-dependent subjects. To characterize the PK profile of ALA-1000 in 5 single ascending dose cohorts and a sixth cohort of single ALA-1000 after receiving buprenorphine sublingual films for 7 days.
Timeline
- Start
- 2019-09-16
- Primary completion
- 2021-05-03
- Completion
- 2021-05-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALA-1000 | Unknown | — | Subcutaneous |
| Subject | Buprenorphine | Other / unclassified | — | Other |