Actively Recruiting
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
Led by Clear Scientific, Inc. · Updated on 2026-05-29
16
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
C
Clear Scientific, Inc.
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and efficacy of CS-1103 given by intravenous infusion in healthy adults aged 18 to 55. This study involves a fentanyl challenge combined with naloxone blockade to assess how CS-1103 interacts with these drugs. The study is a randomized, double-blind, placebo-controlled Phase 2 trial sponsored by Clear Scientific, Inc., focusing on fentanyl overdose and poisoning scenarios. Participants receive naloxone (400 mcg IV) first, followed by fentanyl (200 mcg IV), and then either CS-1103 (1,000 mg IV) or a placebo (saline) infusion. The trial compares the effects of CS-1103 against placebo under these controlled drug administration conditions. The study includes a single dose of the investigational drug administered intravenously after fentanyl and naloxone. During the study, participants are closely monitored for adverse events through physical exams, ECGs, vital signs, and laboratory tests over a period of three days plus a follow-up on Day 10. Blood and urine samples are collected for up to 48 hours to measure CS-1103 and fentanyl levels. The trial also evaluates the impact of CS-1103 on QT intervals and naloxone pharmacokinetics. Total participation lasts through these monitoring and follow-up periods to ensure safety and gather efficacy data.
CONDITIONS
Brief Title
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants aged 18 to 55 years, inclusive
- Prior experience with opioids, such as from dental procedures, chronic pain treatment, or previous surgery
- Body mass index between 18.0 to 30.0 kg/m2 and minimum body weight of 56 kg
- Females must not be lactating and must have a negative pregnancy test during screening and admission
You will not qualify if you...
- Estimated glomerular filtration rate less than 90 mL/min/1.73 m2
- History of cardiovascular disease
- Any clinically important disease or disorder that may interfere with safe study participation, as judged by the investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive naloxone blockade, followed by fentanyl, and then a single dose of either CS-1103 or placebo intravenously.
1 treatment visit (in-person)
Duration - 10 days
Participants are monitored for safety and pharmacokinetic outcomes including adverse events, vital signs, ECGs, laboratory parameters, and drug concentrations.
Approximately 6 visits (in-person) over 10 days
Trial Site Locations
Total: 1 location
1
California Clinical Trials Medical Group
Glendale, California, United States, 91206
Actively Recruiting
Research Team
A
Anna Del Rosario, B.S.
P
Piercen Oliver, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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