Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
STI-1558
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring covid19, COVID-19
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
- Any marketed medication within 14 days or 5 times the half-life, whichever is longer, prior to the first dose of study drug
- Vaccinated within 14 days prior to the first dose of study drug or plans to be vaccinated during the study
- Is unwilling to abstain from quinine containing products or grapefruit during the study
- Use of BCRP substrates within 7 days prior to the first dose of study drug
- A known history of drug abuse within 2 years before screening or positive drug abuse test at screening
- Blood donation or blood loss > 400 mL within 3 months prior to screening
- Weekly alcohol consumption of more than 14 units of alcohol in any week within the past 3 months prior to screening, or intake of alcohol within 48 hours prior to first dose of study drug, or cannot abstain from alcohol during the study, or positive breath alcohol test at screening or Day -1
- Significant smoking history within 3 months before screening
- Excessive drinking of caffeinated beverages within 3 months before screening, or intake of caffeine-containing products within 48 hours prior to the first dose of study drug
- Have human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test
- Positive SARS-CoV-2 test on Day -1
- Subjects who are judged as not eligible to participate in this study as determined by the investigator or designee
Sites / Locations
- Scientia Clinical Research Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
STI-1558
Placebo
Arm Description
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
Subjects will receive placebo orally following either the SAD or MAD dosing schedule
Outcomes
Primary Outcome Measures
Incidence of adverse events (AEs) (safety)
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
Cardiac function (safety)
Heart function as assessed by 12-lead electrocardiogram
Secondary Outcome Measures
AUC of STI-1558 (PK)
Area under the serum concentration-time curve (AUC) of STI-1558
Cmax of STI-1558
Maximum observed serum concentration (Cmax) of STI-1558
t1/2 of STI-1558
Apparent serum terminal elimination half life (t1/2) of STI-1558
Tmax of STI-1558
Time to Cmax (Tmax) of STI-1558
Full Information
NCT ID
NCT05364840
First Posted
April 15, 2022
Last Updated
January 26, 2023
Sponsor
Sorrento Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05364840
Brief Title
Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
October 18, 2022 (Actual)
Study Completion Date
November 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sorrento Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
covid19, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STI-1558
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo orally following either the SAD or MAD dosing schedule
Intervention Type
Drug
Intervention Name(s)
STI-1558
Intervention Description
Orally available protease inhibitor capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo product capsule
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs) (safety)
Description
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
Time Frame
baseline through study completion at up to 42 days
Title
Cardiac function (safety)
Description
Heart function as assessed by 12-lead electrocardiogram
Time Frame
baseline through study completion at up to 42 days
Secondary Outcome Measure Information:
Title
AUC of STI-1558 (PK)
Description
Area under the serum concentration-time curve (AUC) of STI-1558
Time Frame
baseline through study completion at up to 42 days
Title
Cmax of STI-1558
Description
Maximum observed serum concentration (Cmax) of STI-1558
Time Frame
baseline through study completion at up to 42 days
Title
t1/2 of STI-1558
Description
Apparent serum terminal elimination half life (t1/2) of STI-1558
Time Frame
baseline through study completion at up to 42 days
Title
Tmax of STI-1558
Description
Time to Cmax (Tmax) of STI-1558
Time Frame
baseline through study completion at up to 42 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Any marketed medication within 14 days or 5 times the half-life, whichever is longer, prior to the first dose of study drug
Vaccinated within 14 days prior to the first dose of study drug or plans to be vaccinated during the study
Is unwilling to abstain from quinine containing products or grapefruit during the study
Use of BCRP substrates within 7 days prior to the first dose of study drug
A known history of drug abuse within 2 years before screening or positive drug abuse test at screening
Blood donation or blood loss > 400 mL within 3 months prior to screening
Weekly alcohol consumption of more than 14 units of alcohol in any week within the past 3 months prior to screening, or intake of alcohol within 48 hours prior to first dose of study drug, or cannot abstain from alcohol during the study, or positive breath alcohol test at screening or Day -1
Significant smoking history within 3 months before screening
Excessive drinking of caffeinated beverages within 3 months before screening, or intake of caffeine-containing products within 48 hours prior to the first dose of study drug
Have human immunodeficiency virus (HIV) infection, human T-cell leukemia virus type 1 (HTLV1) infection, or hepatitis B virus (HBV) or hepatitis C virus (HCV) viremia or are at risk for HBV reactivation (at risk for HBV reactivation is defined as being HBs antigen positive, or anti-HBc-antibody positive), or are positive for HBV deoxyribonucleic acid (DNA). HCV ribonucleic acid (RNA) must be undetectable by laboratory test
Positive SARS-CoV-2 test on Day -1
Subjects who are judged as not eligible to participate in this study as determined by the investigator or designee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Royal, MD
Organizational Affiliation
Sorrento Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Scientia Clinical Research Ltd
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
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