Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
NCT ID: NCT05484414
Last Updated: 2024-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
56 participants
INTERVENTIONAL
2025-07-16
2026-03-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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Experimental
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
SRP-3D (diethylamide)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Placebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Placebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Interventions
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SRP-3D (diethylamide)
SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Placebo
Matching Placebo for SRP-3D (Diethylamide) Oral Suspension, 100 mg/mL
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is between 18 and 55 years of age (inclusive).
3. Able to speak and understand English or Spanish.
4. Agrees to comply with testing procedures.
5. Has a body mass index (BMI) between 18.0 and 32.0 kg/m2 (inclusive).
6. The subject meets good health criteria.
7. Females of non-childbearing potential or agree to use birth control.
8. Male subjects must be surgically sterile or agree to the use birth control.
9. Agree to the confinement period and return for the outpatient visits.
10. Has vital signs at screening within appropriate ranges.
Exclusion Criteria
2. Abnormal diet 4 weeks preceding the first dose of study medication.
3. Received any investigational product in a clinical study.
4. Previously been administered IMP in this study.
5. Taking any prescribed or OTC drug.
6. Taking moderate or strong inhibitors/inducers of cytochrome P450.
7. History of hypersensitivity to acetaminophen or similar chemical entities.
8. Presence or history of allergy or blood or plasma donation.
9. Blood or plasma donation
10. Smokers and those who have smoked within the last 12 months.
11. Current users of e-cigarettes and nicotine replacement products.
12. Consumption of prohibited beverages or foods.
13. Prior history of substance abuse or treatment.
14. Regular alcohol consumption.
15. Positive alcohol urine test at screening or admission.
16. Is a female with a positive pregnancy test result.
17. Positive urine screen for drugs of abuse.
18. Positive test for hepititus B or C, or HIV.
19. Active infection, periodontal disease,. certain dental appliances.
20. Glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
21. Significant serious skin disease.
22. Cohort 3 only: history of cholecystectomy or gall stones.
23. Have poor venous access that limits phlebotomy
24. Evidence of current SARS-CoV-2 infection
25. Clinically significant abnormal clinical chemistry, hematology or urinalysis.
26. Immediate family members of a study site or Sponsor employee.
27. Failure to satisfy the Investigator of fitness to participate.
18 Years
55 Years
ALL
Yes
Sponsors
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South Rampart Pharma, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Hernan A Bazan, MD
Role: STUDY_CHAIR
CEO
Locations
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Quotient Sciences-Miami, Inc.
Miami, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Other Identifiers
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SRP-101
Identifier Type: -
Identifier Source: org_study_id