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NCT07459166 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade
A Phase 2 study, sponsored by Clear Scientific.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT07459166: Recruiting Phase 2 study, sponsored by Clear Scientific.
NCT07459166 is a Phase 2 study that is actively recruiting participants, run by Clear Scientific. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07459166, a Phase 2 study, is actively recruiting participants, sponsored by Clear Scientific.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study 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).
Primary Outcome
Physical examinations
Interventions
- DRUG Sterile Saline
- DRUG CS-1103
- DRUG Fentanyl
- DRUG Naloxone Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2026-05-28 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
What NCT07459166 shows while recruiting
NCT07459166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 4 interventions - of which Sterile Saline is the first listed.
NCT07459166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07459166 about?
NCT07459166 is a clinical study titled "A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade". 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 is the current status of trial NCT07459166?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2026-05-28. Estimated completion is 2026-10.
What interventions are being tested in trial NCT07459166?
The interventions under investigation include: Sterile Saline (DRUG), CS-1103 (DRUG), Fentanyl (DRUG), Naloxone Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT07459166?
This trial is sponsored by Clear Scientific, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07459166's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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