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A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Sponsor: Clear Scientific, Inc.
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).
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
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
16
Start Date
2026-04
Completion Date
2026-10
Last Updated
2026-03-27
Healthy Volunteers
Yes
Conditions
Interventions
Naloxone Hydrochloride
Naloxone for intravenous administration
Fentanyl
Fentanyl for intravenous administration
Sterile Saline
Sterile Saline for intravenous administration
CS-1103
CS-1103 for intravenous administration
Locations (1)
California Clinical Trials Medical Group
Glendale, California, United States