NCT07459166PHASE2RecruitingAccepts Healthy Volunteers
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Clear Scientific, Inc.
Start Date
5/28/2026
Completion Date
10/1/2026
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).
Eligibility Criteria
Age Range: 18 years to 55 years
Major Inclusion Criteria:
1. Healthy participants aged 18 to 55 years, inclusive;
2. Have prior experience with opioids, such as from a dental procedure, chronic pain management, or previous inpatient surgical procedure;
3. A body mass index between 18.0 to 30.0 kg/m2, inclusive, and a minimum body weight of 56 kg;
4. Females must not be lactating and must have a negative pregnancy test during screening and admission.
Major Exclusion Criteria:
1. Estimated glomerular filtration rate \<90 mL/min/1.73 m2;
2. History of cardiovascular disease;
3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
Interventions
DRUG
Naloxone Hydrochloride
DRUG
Fentanyl
DRUG
Sterile Saline
DRUG
CS-1103
Conditions
Fentanyl OverdoseFentanyl Poisoning
Locations
California Clinical Trials Medical Group
Glendale, California 91206
United States