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

Launched by SOUTH RAMPART PHARMA, LLC · Aug 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SRP-3D, which is being tested to see how safe it is and how the body processes it. The study is divided into two parts and is designed to compare the new medication with a placebo (a fake treatment that looks like the real one but doesn't contain any active ingredients). It is aimed at adults aged 18 to 55 who are in good health and can speak and understand English or Spanish. Some of the requirements to join include having a healthy body weight and agreeing to follow the study's procedures, like returning for follow-up visits.

Participants in the trial can expect to receive either the new medication or a placebo, and they will be closely monitored throughout the study to ensure their safety. It’s important to note that certain people, such as those with significant health issues, those who smoke, or those taking specific medications, won’t be eligible to participate. This is a great opportunity for healthy individuals to contribute to medical research and potentially help others dealing with pain in the future.

Gender

ALL

Eligibility criteria

• 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 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.