Status: Recruiting
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
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).
Participants needed: 16
Trial details
Phase: Phase 2Age: 18-55Biological sex: AllType: InterventionalSponsor: Clear Scientific, Inc.Updated: Jul 1, 2026Locations: 1
Eligibility criteria
Healthy participants aged 18 to 55 years, inclusive; [+3]
Estimated glomerular filtration rate <90 mL/min/1.73 m2; [+2]