SRP-3D (diethylamide) for Pain

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
PainSRP-3D (diethylamide) - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if a new drug is effective and safe. Half the participants will receive the drug and half will receive a placebo. The trial is double-blind, meaning neither the participants nor the researchers will know who is receiving the drug or the placebo.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: The time of providing written informed consent until 30 days after the last dose of study drug

6 days
PK parameters
Day 30
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Experimental
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

56 Total Participants · 2 Treatment Groups

Primary Treatment: SRP-3D (diethylamide) · Has Placebo Group · Phase 1

Experimental
Drug
Experimental Group · 1 Intervention: SRP-3D (diethylamide) · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: the time of providing written informed consent until 30 days after the last dose of study drug

Who is running the clinical trial?

South Rampart Pharma, LLCLead Sponsor
Hernan A Bazan, MDStudy ChairCEO

Eligibility Criteria

Age 18 - 55 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Patients must be between 18 and 55 years of age (inclusive).
You have a body mass index (BMI) between 18.0 and 32.
You have good health.
You agree to the confinement period and return for the outpatient visits.
You are female and not of childbearing potential or agree to use birth control.
You are male and you must be surgically sterile or agree to the use of birth control.

Who else is applying?

What state do they live in?
Florida50.0%
New York50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Quotient Sciences-Miami, Inc.100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Phone Call100.0%
Most responsive sites:
  1. Quotient Sciences-Miami, Inc.: < 24 hours
Average response time
  • < 1 Day