Last reviewed · How we verify
Safety, Tolerability, and Pharmacokinetics of CSX-1004
This is a Phase 1a, randomized, double-blind, single ascending dose study, designed to assess the safety, tolerability, and PK of a single CSX-1004 injection, administered by IV infusion across a range of doses in healthy adult subjects. The study will have 3 phases: Screening, Inpatient Treatment, and Outpatient Follow-up. The primary objective of the study is to determine the safety and tolerability of CSX-1004 Injection administered by intravenous (IV) infusion across a range of doses in healthy adult subjects. The secondary objective of the study is to determine the pharmacokinetics (PK) of CSX-1004 Injection administered by IV infusion across a range of doses in healthy adult subjects.
Details
| Lead sponsor | Cessation Therapeutics, Inc. |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | Tue Aug 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue May 28 2024 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Opioid Overdose
- Opioid Use Disorder
Interventions
- CSX-1004
- Placebo
Countries
United States