SRP-3D for Pain Management
Trial Summary
What is the purpose of this trial?
This trial tests a new drug called SRP-3D (DA) in a general study group. It aims to gather information on safety and how the drug behaves in the body.
Will I have to stop taking my current medications?
Yes, participants must stop taking any prescribed or over-the-counter drugs to be eligible for this trial.
How does the drug SRP-3D differ from other pain management drugs?
The drug SRP-3D (diethylamide) is unique because it may involve a novel mechanism of action or administration route compared to standard opioid treatments, which typically target specific opioid receptors like mu and delta. While the research does not directly mention SRP-3D, it highlights the potential for new opioid compounds like AM 94, which have shown greater and longer-lasting pain relief in animal studies, suggesting SRP-3D might offer similar innovative benefits.12345
Research Team
Hernan A Bazan, MD
Principal Investigator
CEO
Eligibility Criteria
This trial is for healthy men and women aged 18-55 who are not pregnant or breastfeeding. Participants must understand English or Spanish, have a BMI of 18-32, agree to use birth control if applicable, and commit to the study schedule including inpatient stays and outpatient visits.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
SAD (Single Ascending Dose) Assessment
Participants receive single ascending doses of SRP-3D (DA) to assess safety and pharmacokinetics, including a food effect assessment
MAD (Multiple Ascending Dose) Assessment
Participants receive multiple ascending doses of SRP-3D (DA) to assess safety and pharmacokinetics
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- SRP-3D (diethylamide)
Find a Clinic Near You
Who Is Running the Clinical Trial?
South Rampart Pharma, LLC
Lead Sponsor