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

This is a two-part randomized, double-blind, placebo-controlled study. The study comprises a SAD (Part 1) assessment which will include a food effect assessment that contributes data to inform a subsequent MAD (Part 2) dose-ranging study. Safety measurements will be collected throughout the study for all subjects. Blood samples will be collected to determine the PK parameters of SRP-3D (DA).

Inclusion criteria

• 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.

Exclusion criteria

• 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 hepatitis 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.
• Immediate family members of a study site or Sponsor employee.
• Failure to satisfy the Investigator of fitness to participate.