A Randomized, Double-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Oral Doses of STI-1558 in Healthy Volunteers
Overview
- Phase
- Phase 1
- Intervention
- STI-1558
- Conditions
- COVID-19
- Sponsor
- Sorrento Therapeutics, Inc.
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Cardiac function (safety)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is a Phase 1, two-part, randomized, double blind, placebo controlled, ascending dose study to evaluate the safety, tolerability, pharmacokinetics of STI-1558 administered orally to healthy volunteers.
Detailed Description
This is a Phase 1, two-part, randomized, double blind, placebo controlled, single ascending dose (Part 1) and multiple ascending dose (Part 2) study to evaluate the safety, tolerability, pharmacokinetics (PK) of STI-1558 administered orally to healthy volunteers. Part 1 of the study will also incorporate a single-cohort arm to investigate the effect of food on the PK of STI-1558. Dietary status of administration in part 2 (fasted or fed) will be determined by the PK data from Part 1. Part 2 may run in parallel with Part 1, providing that the total daily dose to be administered does not exceed a dose already shown to be safe and well-tolerated in Part 1.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) is between 18 and 30 kg/m2 (both inclusive), and Body weight between 45 and 100 kg (inclusive)
- •Generally normal, or abnormal with no clinical significance as judged by the primary investigator based on physical examination, vital signs, electrocardiogram, and clinical laboratory tests
- •Willing to follow contraception guidelines
- •Willing and able to comply with study procedures and follow-up visits
Exclusion Criteria
- •Difficulty or history of dizziness during venous blood collection or encountering blood or needles
- •Known or suspected pregnancy, planned pregnancy, a positive pregnancy test at screening or are breastfeeding
- •A clinically relevant intolerance or allergy to drugs, or are known or suspected to have hypersensitivity to any ingredient in STI-1558 capsules
- •Received an experimental agent within 1 month or 5 times half-life (whichever is longer) prior to the first dose of study drug
- •Has a history of gastrointestinal, liver or kidney disease, or other condition that may exclude the subject as determined by the investigator
- •Has a medical history of significant diseases as determined by the investigator
- •Has a history of febrile illness within 14 days prior to the first dose of study drug
- •Has values above the upper limit of normal alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase at screening or Day -1 and judged to be clinically significant by the investigator
- •Prolonged QTcF interval
- •Has had major surgery within 3 months prior to the first dose of study drug or plans to undergo surgery during the study
Arms & Interventions
STI-1558
Subjects will receive in each part either a single ascending dose (SAD): 300 mg, 600 mg, 1200 mg, 2000 mg on Day1 or as part of the multiple ascending dose (MAD): 300 mg, 600 mg, and 800 mg twice a day for 7.5 days
Intervention: STI-1558
Placebo
Subjects will receive placebo orally following either the SAD or MAD dosing schedule
Intervention: Placebo
Outcomes
Primary Outcomes
Cardiac function (safety)
Time Frame: baseline through study completion at up to 42 days
Heart function as assessed by 12-lead electrocardiogram
Incidence of adverse events (AEs) (safety)
Time Frame: baseline through study completion at up to 42 days
Safety as assessed by incidence of AEs by type, frequency, severity, and causality using the Common Terminology Criteria for Adverse Events, Version 5 (CTCAEv5) Safety as assessed by incidence of adverse events, clinically significant changes in safety lab results, physical exam, vital signs, and electrocardiogram
Secondary Outcomes
- AUC of STI-1558 (PK)(baseline through study completion at up to 42 days)
- Cmax of STI-1558(baseline through study completion at up to 42 days)
- t1/2 of STI-1558(baseline through study completion at up to 42 days)
- Tmax of STI-1558(baseline through study completion at up to 42 days)