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

Starting soon · Phase 1 · Has a placebo group

Conditions studied: Pain

In brief

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

Key facts

Study ID

NCT05484414

Run by

South Rampart Pharma, LLC

People needed

56

Starts

2025-07-16

Expected to finish

2026-03-28

Last updated by the study team

2024-12-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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.
• Is a female with a positive pregnancy test result.
• Positive urine screen for drugs of abuse.
• Positive test for hepititus B or C, or HIV.
• Active infection, periodontal disease,. certain dental appliances.
• Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
• Significant serious skin disease.
• Cohort 3 only: history of cholecystectomy or gall stones.
• Have poor venous access that limits phlebotomy
• Evidence of current SARS-CoV-2 infection
• Clinically significant abnormal clinical chemistry, hematology or urinalysis.

Where it is running

• Quotient Sciences-Miami, Inc. — Miami, Florida, United States

Full record on ClinicalTrials.gov

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