Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)

A 2 Part Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA), and to Characterize the Effect of Food on the Pharmacokinetics in Healthy Male and Female Subjects

This is a two-part randomized, double-blind, placebo-controlled study.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Drug: SRP-3D (diethylamide); Drug: Placebo

Detailed Description

This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Manager; Phone Number: 8007693518; Email: info@southrampartpharma.com

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Quotient Sciences-Miami, Inc.
      • Contact: Principal Investigator; Phone Number: 115 305-644-9903; Email: maria.bermudez@quotientsciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female. Females must not be pregnant or breastfeeding.
2. Is between 18 and 55 years of age (inclusive).
3. Able to speak and understand English or Spanish.
4. Agrees to comply with testing procedures.
5. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
6. The subject meets good health criteria.
7. Females of non-childbearing potential or agree to use birth control.
8. Male subjects must be surgically sterile or agree to the use birth control.
9. Agree to the confinement period and return for the outpatient visits.
10. Has vital signs at screening within appropriate ranges.

Exclusion Criteria:

1. History or presence of clinically significant diseases.
2. Abnormal diet 4 weeks preceding the first dose of study medication.
3. Received any investigational product in a clinical study.
4. Previously been administered IMP in this study.
5. Taking any prescribed or OTC drug.
6. Taking moderate or strong inhibitors/inducers of cytochrome P450.
7. History of hypersensitivity to acetaminophen or similar chemical entities.
8. Presence or history of allergy or blood or plasma donation.
9. Blood or plasma donation
10. Smokers and those who have smoked within the last 12 months.
11. Current users of e-cigarettes and nicotine replacement products.
12. Consumption of prohibited beverages or foods.
13. Prior history of substance abuse or treatment.
14. Regular alcohol consumption.
15. Positive alcohol urine test at screening or admission.
16. Is a female with a positive pregnancy test result.
17. Positive urine screen for drugs of abuse.
18. Positive test for hepititus B or C, or HIV.
19. Active infection, periodontal disease,. certain dental appliances.
20. Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
21. Significant serious skin disease.
22. Cohort 3 only: history of cholecystectomy or gall stones.
23. Have poor venous access that limits phlebotomy
24. Evidence of current SARS-CoV-2 infection
25. Clinically significant abnormal clinical chemistry, hematology or urinalysis.
26. Immediate family members of a study site or Sponsor employee.
27. Failure to satisfy the Investigator of fitness to participate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL	Drug: SRP-3D (diethylamide); SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL; Other Names: SRP-3D (DA)
Placebo Comparator: Placebo; Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL	Drug: Placebo; Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL; Other Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	Reported AEs	The time of providing written informed consent until 30 days after the last dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters 1	Lag time (Tlag)	6 days
PK parameters 2	Time to reach maximum (peak) plasma concentration following drug administration (Tmax)	6 days
PK parameters 3	Maximum (peak) plasma drug concentration (Cmax)	6 days
PK parameters 4	Area under the plasma concentration-time curve from time zero to infinity (AUCinf)	6 days
PK parameters 5	Area under the plasma concentration-time curve from time zero to infinity (AUClast)	6 days
PK parameters 6	Area under the plasma concentration-time curve (AUC0-tau)	6 days
PK parameters 7	Terminal disposition rate constant/terminal rate constant (λz)	6 days
PK parameters 8	Elimination half-life (T1/2)	6 days
PK parameters 9	Apparent total clearance of the drug from plasma after oral administration (CL/F)	6 days
PK parameters 10	Apparent volume of distribution during terminal phase after non-intravenous administration (Vz/F)	6 days

Collaborators and Investigators

• Sponsor: South Rampart Pharma, LLC
• Investigators: Study Chair: Hernan A Bazan, MD, CEO

Study record dates

Study Major Dates

• Study Start (Estimated): July 16, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): March 28, 2026

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 1, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Pain
• Other Study ID Numbers: SRP-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No