NCT05484414

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: South Rampart Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

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).

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	SRP-3D (diethylamide)	SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
DRUG	Placebo	Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Timeline

• Start date: 2025-07-16
• Primary completion: 2025-12-31
• Completion: 2026-03-28
• First posted: 2022-08-02
• Last updated: 2024-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study