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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05364840




Registration number
NCT05364840
Ethics application status
Date submitted
15/04/2022
Date registered
6/05/2022
Date last updated
30/01/2023

Titles & IDs
Public title
Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
MPR-COV-101AU
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - STI-1558
Treatment: Drugs - Placebo

Experimental: 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

Placebo Comparator: Placebo - Subjects will receive placebo orally following either the SAD or MAD dosing schedule


Treatment: Drugs: STI-1558
Orally available protease inhibitor capsule

Treatment: Drugs: Placebo
Placebo product capsule
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of adverse events (AEs) (safety)
Timepoint [1] 0 0
baseline through study completion at up to 42 days
Primary outcome [2] 0 0
Cardiac function (safety)
Timepoint [2] 0 0
baseline through study completion at up to 42 days
Secondary outcome [1] 0 0
AUC of STI-1558 (PK)
Timepoint [1] 0 0
baseline through study completion at up to 42 days
Secondary outcome [2] 0 0
Cmax of STI-1558
Timepoint [2] 0 0
baseline through study completion at up to 42 days
Secondary outcome [3] 0 0
t1/2 of STI-1558
Timepoint [3] 0 0
baseline through study completion at up to 42 days
Secondary outcome [4] 0 0
Tmax of STI-1558
Timepoint [4] 0 0
baseline through study completion at up to 42 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/11/2022
Sample size
Target
Accrual to date
Final
58
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sorrento Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05364840
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Mike Royal, MD
Address 0 0
Sorrento Therapeutics, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries