Back to search results

Phase 2 Study of CS-1103 for Fentanyl Overdose

This study is testing a new drug called CS-1103 to see how safe and effective it is in healthy volunteers. Researchers want to understand how CS-1103 works in your body (pharmacokinetics) when you've also received fentanyl (a strong pain medication) and naloxone (a medication used to reverse opioid effects). The main goal is to track any side effects from CS-1103 through physical exams, heart tests (electrocardiograms or ECGs), and checking your vital signs for about 10 days. You might be able to join if you are a healthy adult between 18 and 55 years old, have some past experience with opioids (like for dental work or pain management), and meet certain weight requirements. The study plans to enroll 16 participants, but its current recruitment status is unclear.

Study design
This is an interventional study involving 16 healthy participants. It is designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CS-1103.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events for 3 days, with a follow-up on Day 10.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07459166

A Phase 2 Safety, Tolerability, PK, and Efficacy Study of CS-1103 Following Fentanyl Challenge With Naloxone Blockade

Recruiting
PHASE2Ages 18–55InterventionalTreatment
Clear Scientific, Inc.
~16 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Naloxone HydrochlorideFentanylSterile SalineCS-1103

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations
Measured over 3 days plus follow-up on Day 10
+5 more outcomes measured

Conditions

Fentanyl Overdose
Fentanyl Poisoning

Explore related trials

Healthy Volunteers

NCT07459166

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • California Clinical Trials Medical Group

    Glendale, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Xinhua Li, Ph.D. · PRINCIPAL_INVESTIGATOR · Clear Scientific, Inc.

Who to contact

Anna Del Rosario, B.S.
[email protected]
617-621-8500
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

What this trial measures

  • Number of participants with CS-1103-related adverse events (AEs) assessed by physical examinations3 days plus follow-up on Day 10

    Physical examinations

  • Number of participants with CS-1103-related adverse events (AEs) assessed by electrocardiograms (ECGs)3 days plus follow-up on Day 10

    Digital 12-lead electrocardiograms (ECGs). Any correlation between CS-1103 plasma concentrations and changes in QT intervals will be noted

  • Number of participants with CS-1103-related adverse events (AEs) assessed by vital signs3 days plus follow-up on Day 10

    Blood pressure, pulse rate, respiratory rate, oxygen saturation, and body temperature

  • Number of participants with CS-1103-related adverse events (AEs) assessed by laboratory parameters3 days plus follow-up on Day 10

    Clinical chemistry, hematology, coagulation, and urinalysis

  • Time course of CS-1103 blood and urine concentrations48 hours

    Measurement of plasma and urine concentrations of CS-1103

  • Time course and magnitude of urine excretion of fentanyl48 hours

    Measurement of concentration of fentanyl in urine