SRP-3D for Pain Management
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new pain management treatment called SRP-3D (diethylamide), administered as an oral suspension. Researchers aim to evaluate the safety and effectiveness of this treatment compared to a placebo (a harmless pill with no active medication). The trial seeks healthy adults without significant health issues or a history of allergies to certain medications. Participants must follow the study procedures and attend all required visits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
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.
Is there any evidence suggesting that SRP-3D (diethylamide) is likely to be safe for humans?
Research shows that SRP-3D (diethylamide) is being tested for safety in humans. This treatment resembles acetaminophen but functions differently and does not harm the liver. In earlier animal studies, it did not produce NAPQI, a substance often linked to liver damage.
SRP-3D is currently in a Phase 1 trial, marking the first step in human testing. This phase focuses on assessing the drug's safety and understanding its metabolism in the body. Although human study data is limited, the absence of liver damage in animals is promising. Prospective participants should note that Phase 1 trials are specifically designed to closely monitor safety.12345Why do researchers think this study treatment might be promising?
Unlike standard pain management options like opioids and NSAIDs, SRP-3D uses diethylamide as its active ingredient, offering a novel approach to pain relief. This treatment is administered as an oral suspension, which can be easier to take compared to pills or injections. Researchers are excited because diethylamide may offer pain relief with potentially fewer side effects than traditional medications, addressing a critical need for safer pain management solutions.
What evidence suggests that SRP-3D might be an effective treatment for pain management?
Research shows that SRP-3D (diethylamide), which participants in this trial may receive, may effectively manage pain. Early evidence indicates that similar compounds can significantly reduce pain. Researchers have studied this treatment for its ability to relieve pain without harming the liver or kidneys, a common issue with other pain relievers like acetaminophen. Initial findings also suggest it might improve the quality of life for people with long-term pain. This offers hope that SRP-3D could benefit those with ongoing pain issues.12678
Who Is on the Research Team?
Hernan A Bazan, MD
Principal Investigator
CEO
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Placebo
- SRP-3D (diethylamide)
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Who Is Running the Clinical Trial?
South Rampart Pharma, LLC
Lead Sponsor