SRP-3D for Pain Management

Overseen By Study Manager

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: South Rampart Pharma, LLC

Must not be taking: Prescribed drugs, OTC drugs

Disqualifiers: Significant diseases, Substance abuse, others

Compensation: Varies

Number of Visits: Unknown

56 Participants Needed

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. ^{1 2 3 4 5}

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

Your basic body measurements are within normal ranges.

I agree to stay in the hospital when needed and come back for follow-up visits.

You are a healthy man or woman who is not pregnant or breastfeeding.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

SAD (Single Ascending Dose) Assessment

Participants receive single ascending doses of SRP-3D (DA) to assess safety and pharmacokinetics, including a food effect assessment

6 days

MAD (Multiple Ascending Dose) Assessment

Participants receive multiple ascending doses of SRP-3D (DA) to assess safety and pharmacokinetics

6 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Placebo
• SRP-3D (diethylamide)

Trial Overview The study tests SRP-3D (diethylamide), a new drug for pain relief. It's compared with a placebo in two parts: single ascending dose (SAD) and multiple ascending dose (MAD). The process is randomized and double-blind, meaning neither participants nor researchers know who gets the real drug.

Participant Groups

Group I: Experimental Experimental Treatment 1 Intervention

SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Group II: Placebo Placebo Group 1 Intervention

Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Who Is Running the Clinical Trial?

South Rampart Pharma, LLC

Lead Sponsor

Trials

1

Recruited

60+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The analgesic activity of biphalin and its analog AM 94 in rats. [2013]

2. United States pubmed.ncbi.nlm.nih.gov

Mu opioid antagonist properties of a cyclic somatostatin octapeptide in vivo: identification of mu receptor-related functions. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Intrathecal opioids block a spinal action of substance P in mice: functional importance of both mu- and delta-receptors. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Antinociceptive profile of potent opioid peptide AM94, a fluorinated analogue of biphalin with non-hydrazine linker. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Morphine (intracerebroventricular) activates spinal systems to inhibit behavior induced by putative pain neurotransmitters. [2013]