A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
Recruiting
Phase 2
Interventional Study
Fentanyl Overdose
Fentanyl Poisoning
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 – 55
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 16 (estimated)
- Sponsor
- Clear Scientific, Inc. · Industry
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About This Trial
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).
Trial Locations
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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…
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