New drug CS-1103 tested as potential fentanyl overdose treatment
NCT ID NCT07459166
First seen Jun 26, 2026 · Last updated Aug 25, 2026 · Updated 5 times
Summary
This Phase 2 trial tests a single dose of CS-1103 in 16 healthy adults who also receive fentanyl (a strong opioid) and naloxone (an overdose reversal drug). The goal is to see if CS-1103 is safe and how it affects fentanyl levels in the body. It is an early study to gather safety data, not yet testing in real overdose situations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CS-1103
- What this could lead to
- If successful, this could point toward a new treatment for fentanyl overdose, potentially offering an alternative to naloxone.
- What could go wrong
- This is a very early, small Phase 2 trial in healthy volunteers, not real overdose patients. It may not work in actual emergencies or have unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 16 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Oct 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<90 mL/min/1.73 m2; 2. History of cardiovascular disease; 3. History of any clinically important disease or disorder which, in the opinion of the Investigator, may interfere with safe study participation.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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California Clinical Trials Medical Group
RECRUITINGGlendale, California, 91206, United States
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