drugset / Trial / NCT06216132
Study of the BIOPIN 6 Naltrexone Implant in Healthy Adults
Phase 1
Completed
16 enrolled
Akyso Therapeutics, LLC
Cognitive Research Corporation · collabLaboratory Corporation of America · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and blood levels of a medicine, naltrexone, contained within an implant in healthy volunteers age 18 to 65 years. To do this, the implant containing the drug will be inserted under the skin, left in place for 3 months and then removed.
Timeline
- Start
- 2024-06-24
- Primary completion
- 2025-04-18
- Completion
- 2025-04-25
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 4.8 g | Subcutaneous |
| Subject | Naltrexone | Small molecule | 9.6 g | Subcutaneous |