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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 is a Phase 2 study that is actively recruiting participants, run by Clear Scientific. The registered enrollment target is 16 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07459166
The ClinicalTrials.gov registry entry for NCT07459166 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clear Scientific, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Sterile Saline is the first listed.
NCT07459166 reports 0 study locations.
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.
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