What this study is
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).
What's being tested
- Naloxone Hydrochloride
Intervention · DRUG
Naloxone for intravenous administration
- Fentanyl
Intervention · DRUG
Fentanyl for intravenous administration
- Sterile Saline
Intervention · DRUG
Sterile Saline for intravenous administration
- CS-1103
Intervention · DRUG
CS-1103 for intravenous administration
Study details
- 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
- Sponsor
- Clear Scientific, Inc.
- Conditions
- Fentanyl Overdose · Fentanyl Poisoning
- Enrolling
- 16 people
- Starts
- 2026-05-28
- Est. completion
- 2026-10
- Design
- Quadruple-blind, randomized, parallel groups, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 55 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCalifornia Clinical Trials Medical Group
Glendale, California, United States
- Lev Gertsik, M.D. · Contact888-228-7425study.losangeles@parexel.com
Recruiting
Study team
Sponsor
Clear Scientific, Inc.
Study ID CS-1103-03
Principal investigator
Xinhua Li, Ph.D.
Clear Scientific, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.