A Two-Part randomized, Double-Blind, Placebo-Controlled study to assess the safety, tolerability and pharmacokinetics of single ascending and multiple ascending oral doses of SRP-3D (DA), and to characterize the effect of food on the pharmacokinetics of SRP-3D (DA), in healthy male and female subjects
NCT ID NCT05484414
First seen Sep 10, 2026 ยท Last updated Sep 10, 2026
Summary
This is a two-part randomized, double-blind, placebo-controlled study.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Dec 2021
- Finished
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Nov 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Healthy male or female. Females must not be pregnant or breastfeeding. 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: 1. History or presence of clinically significant diseases. 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 hepatitis 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Quotient Sciences-Miami, Inc.
Miami, Florida, 33126, United States
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