Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
NCT05484414 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2024-12-10
Summary
This is a two-part randomized, double-blind, placebo-controlled study.
Conditions
Interventions
- DRUG
-
SRP-3D (diethylamide)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
- DRUG
-
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Sponsors & Collaborators
-
South Rampart Pharma, LLC
lead INDUSTRY
Principal Investigators
-
Hernan A Bazan, MD · CEO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-07-16
- Primary Completion
- 2025-12-31
- Completion
- 2026-03-28
- FDA Drug
- Yes
Countries
- United States
Study Locations
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