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

Part of paid clinical trials in Miami, Florida.

Sponsor
South Rampart Pharma, LLC
Study ID
NCT05484414
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • SRP-3D (diethylamide) — DRUG
    SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
  • Placebo — DRUG
    Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Study Details

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

Key Dates

Start date
Jul 16, 2025
Status verified
Dec 2024
Primary completion
Dec 31, 2025
Completion
Mar 28, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
  • Placebo Comparator: Placebo
    Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Quotient Sciences-Miami, Inc.MiamiFlorida33126
Principal Investigator
[email protected]
305-644-9903

Find similar trials in Miami, FL

By research site
Quotient Sciences-Miami, Inc.· Miami, FL

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