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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Dec 2021

Finished

Nov 2023

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Quotient Sciences-Miami, Inc.

    Miami, Florida, 33126, United States

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