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NCT07459166
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Conditions: Fentanyl Overdose, Fentanyl Poisoning
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 16
Sponsor: Clear Scientific, Inc.
Location: California Clinical Trials Medical Group Glendale California
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
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 \
Source: ClinicalTrials.gov (NCT07459166). StuddyBuddy aggregates publicly available trial information.
