clinical trial · NCT05484414
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
South Rampart Pharma, LLC·phase1·not yet recruiting·n = 56
PainSRP-3D (diethylamide)Placebo
brief summary
This is a two-part randomized, double-blind, placebo-controlled study.
started
Jul 16, 2025
primary completion
Dec 31, 2025
completion
Mar 28, 2026
last updated
Dec 10, 2024
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).
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol