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

NCT05484414 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: SRP-101
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain

Keywords

Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• PK parameters 1

  6 days

• PK parameters 2

  6 days

• PK parameters 3

  6 days

• PK parameters 4

  6 days

• PK parameters 5

  6 days

Study Arms (2)

Experimental

EXPERIMENTAL

SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Drug: SRP-3D (diethylamide)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

SRP-3D (diethylamide) DRUG

SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL

Also known as: SRP-3D (DA)

Experimental

Placebo DRUG

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

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History or presence of clinically significant diseases.
• Abnormal diet 4 weeks preceding the first dose of study medication.
• Received any investigational product in a clinical study.
• Previously been administered IMP in this study.
• Taking any prescribed or OTC drug.
• Taking moderate or strong inhibitors/inducers of cytochrome P450.
• History of hypersensitivity to acetaminophen or similar chemical entities.
• Presence or history of allergy or blood or plasma donation.
• Blood or plasma donation
• Smokers and those who have smoked within the last 12 months.
• Current users of e-cigarettes and nicotine replacement products.
• Consumption of prohibited beverages or foods.
• Prior history of substance abuse or treatment.
• Regular alcohol consumption.
• Positive alcohol urine test at screening or admission.

Sponsors & Collaborators

• South Rampart Pharma, LLC: lead

Study Sites (1)

Quotient Sciences-Miami, Inc.

Miami, Florida, 33126, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hernan A Bazan, MD

  CEO

  STUDY CHAIR

Central Study Contacts

Study Manager

CONTACT

8007693518; info@southrampartpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 2, 2022
• Study Start: July 16, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 28, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)