drugset / Trial / NCT07459166
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Phase 2
Recruiting
16 enrolled
Clear Scientific, Inc.
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 (1,000 mg), given by intravenous (IV) infusion in healthy participants in the presence of a clinically relevant dose of fentanyl (200 μg, IV), with naloxone blockade (400 μg, IV).
Timeline
- Start
- 2026-05-28
- Primary completion
- 2026-07
- Completion
- 2026-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | CS-1103 | Unknown | 1000 mg | Intravenous |
| Comparator | Fentanyl | Other / unclassified | 200 ug | Intravenous |
| Comparator | Naloxone | Small molecule | 400 ug | Intravenous |