clinical trial · NCT07459166
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Clear Scientific, Inc.·phase2·not yet recruiting·n = 16
Fentanyl OverdoseFentanyl PoisoningNaloxone HydrochlorideFentanylSterile SalineCS-1103
brief 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).
started
Apr 1, 2026
primary completion
Jul 1, 2026
completion
Oct 1, 2026
last updated
Mar 27, 2026
official title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of a Single Dose of Intravenous CS 1103 Following a Single Intravenous Dose of Fentanyl in Healthy Subjects With Naloxone Blockade
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol