CS-1103 for Fentanyl Overdose
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test a new treatment, CS-1103, to determine its safety and effectiveness for individuals exposed to a high dose of fentanyl, a powerful painkiller. The study involves two groups: one receives the actual treatment, while the other receives a placebo (an inactive substance). The trial includes healthy individuals with some past opioid experience, possibly from medical procedures. Participants should not have any serious health issues, particularly those related to the heart or kidneys. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CS-1103 is likely safe. In previous studies, participants tolerated it well at doses similar to those currently under testing. Importantly, these studies reported no serious side effects, indicating that CS-1103 did not cause major health problems. This suggests that CS-1103 could be a safe option for those considering joining the trial.12345
Why are researchers excited about this trial's treatments?
Unlike the standard treatment for fentanyl overdose, which typically involves naloxone, CS-1103 offers a fresh approach. Researchers are excited about CS-1103 because it targets different pathways in the body to counteract the effects of fentanyl. This could potentially lead to a more robust and longer-lasting reversal of overdose symptoms, providing an important new tool in emergency medicine. With its unique mechanism of action, CS-1103 might offer benefits where naloxone alone has limitations, sparking hope for better outcomes in overdose situations.
What evidence suggests that this trial's treatments could be effective for fentanyl overdose?
Research has shown that CS-1103 could be a promising treatment for fentanyl overdoses. Laboratory studies indicate that it safely and effectively reverses harmful effects and quickly removes opioids from the body. Early human tests suggest that CS-1103 is well-tolerated, causing few side effects. In this trial, some participants will receive CS-1103 following a naloxone blockade and fentanyl administration. This treatment focuses on removing the opioid itself, not just reversing its effects, potentially offering a new approach to handling overdoses. The FDA has granted CS-1103 a Fast Track designation, highlighting its potential importance in treating opioid overdoses.12346
Who Is on the Research Team?
Xinhua Li, Ph.D.
Principal Investigator
Clear Scientific, Inc.
Are You a Good Fit for This Trial?
This trial is for healthy adults aged 18 to 55 who have used opioids before (like after surgery or dental work), have a BMI between 18 and 30, weigh at least 56 kg, and are not pregnant or breastfeeding.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive naloxone blockade, followed by fentanyl, and then either placebo or CS-1103
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CS-1103
- Naloxone Hydrochloride
Trial Overview
The study tests the safety and effects of a new drug called CS-1103 given by IV after participants receive fentanyl. Naloxone is also used to block opioid effects. The goal is to see how safe CS-1103 is in this setting.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by CS-1103 (1,000 mg, IV).
Participants receive naloxone blockade (400 μg, IV), followed by fentanyl (200 μg, IV), followed by placebo (saline).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Clear Scientific, Inc.
Lead Sponsor
National Institute on Drug Abuse (NIDA)
Collaborator
Citations
CS-1103 - Drug Targets, Indications, Patents
Data from the 99-patient ALSpire study (NCT04494256) demonstrated that BIIB105 failed to significantly reduce neurodegeneration or improve functional measures ...
A Novel Therapeutic Takes Aim at the Fentanyl and Meth ...
Comprehensive preclinical studies conducted by Charles River Laboratories showed that CS-1103 is safe, effective, and ready for clinical trials.
Novel Therapeutic Agents to Reverse Opioid Overdose
Expected outcome is CS-1103 dose for reversal of toxic effects and rapid opioid clearance. Aim 3 will establish the safety profile of CS-1103 for IM ...
4.
clearsci.com
clearsci.com/post/clear-scientific-reports-positive-topline-phase-1-clinical-trial-data-for-cs-1103Clear Scientific Reports Positive Topline Phase 1 Clinical ...
Positive topline data from the First-in-Human Phase 1 clinical trial of its therapeutic CS-1103 that demonstrate a favorable safety and tolerability profile.
5.
chemxpert.com
chemxpert.com/all-news/clear-scientific-wins-fda-fast-track-for-fentanyl-overdose-therapy-cs-1103Clear Scientific Wins FDA Fast Track for Fentanyl Overdose ...
CS-1103 represents a shift from reversal → removal in overdose treatment. Fast Track designation accelerates development; Mechanism addresses a ...
FDA Grants Fast Track Designation for CS-1103, a First-in- ...
CS-1103 was shown to be safe and well tolerated in humans at clinically relevant doses in a Phase 1 clinical trial. Phase 2 trials for Fentanyl ...
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