California Clinical Trials Medical Group
Glendale, California, 91206, United States
Location status: Recruiting
Recruiting
NCT Number: NCT07459166
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).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Major Inclusion Criteria:
- Healthy participants aged 18 to 55 years, inclusive;
- Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
- A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
- Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
- Estimated glomerular filtration rate <90 mL/min/1.73 m2;
- History of cardiovascular disease;
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Treatment and study plan
Naloxone hydrochloride
DrugNaloxone for intravenous administration
Fentanyl
DrugFentanyl for intravenous administration
Sterile Saline
DrugSterile Saline for intravenous administration
CS-1103
DrugCS-1103 for intravenous administration
Primary outcomes
-
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Time frame: 3 days plus follow-up on Day 10
Physical examinations
-
Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)
Time frame: 3 days plus follow-up on Day 10
Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted
-
Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs
Time frame: 3 days plus follow-up on Day 10
Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature
-
Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters
Time frame: 3 days plus follow-up on Day 10
Clinical chemistry, hematology, coagulation, and urinalysis
-
Time course of CS-1103 blood and urine concentrations
Time frame: 48 hours
Measurement of plasma and urine concentrations of CS-1103
-
Time course and magnitude of urine excretion of fentanyl
Time frame: 48 hours
Measurement of concentration of fentanyl in urine
Secondary outcomes
-
Effect of CS-1103 and fentanyl on QT interval
Time frame: 48 hours
Concentration-QT correlation performed on baseline-corrected QTcF time-matched with PK for fentanyl and CS-1103 in plasma
-
Effect of CS-1103 on the naloxone plasma and urine PK, if any
Time frame: 48 hours
Measurement of standard urine and plasma PK parameters between placebo and CS-1103 treated participants
Study contacts
Contact information is provided by the study sponsor or research team.
Anna Del Rosario, B.S.
CONTACT
Piercen Oliver, Ph.D.
CONTACT
Sponsors and collaborators
Lead sponsor
Clear Scientific, Inc.
Industry
Collaborators
- National Institute on Drug Abuse (NIDA)
Registry information
Official study 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
Important dates
- Study start
- 2026
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Mar 9, 2026
- Registry last updated
- Jul 1, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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