Clinical Trial

A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade

Recruiting Phase 2
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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).
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-30
Trial Details
NCT Number NCT07459166
Lead Sponsor Clear Scientific, Inc.
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Fentanyl Overdose, Fentanyl Poisoning
Enrollment 16 participants
Start Date 2026-05-28
Primary Completion 2026-07 (estimated)
Study Completion 2026-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-01