COVID-19Phase 1NCT05364840
Study to Assess the Safety, Tolerability and Pharmacokinetics of STI-1558 in Healthy Volunteers
A Phase 1 study testing STI-1558 in people with COVID-19, run by Sorrento Therapeutics, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- STI-1558
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 1 siteAustralia
- Study dates
- 7 Jun 2022to 4 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Randwick, New South Wales, 2031
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- STI-1558, Placebo
- Keywords
- covid19, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STI-1558Drug
Orally available protease inhibitor capsule
PlaceboDrug
Placebo product capsule
| Study group | Role | What they receive |
|---|---|---|
| STI-1558 | Experimental | 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 Receives: Drug: STI-1558 |
| Placebo | Placebo comparator | Subjects will receive placebo orally following either the SAD or MAD dosing schedule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline through study completion at up to 42 days
Cardiac function (safety)
Heart function as assessed by 12-lead electrocardiogram
Measured: baseline through study completion at up to 42 days
Secondary outcomes (4)
AUC of STI-1558 (PK)
Area under the serum concentration-time curve (AUC) of STI-1558
Measured: baseline through study completion at up to 42 days
Cmax of STI-1558
Maximum observed serum concentration (Cmax) of STI-1558
Measured: baseline through study completion at up to 42 days
t1/2 of STI-1558
Apparent serum terminal elimination half life (t1/2) of STI-1558
Measured: baseline through study completion at up to 42 days
Tmax of STI-1558
Time to Cmax (Tmax) of STI-1558
Measured: baseline through study completion at up to 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start7 Jun 2022
- Primary completion18 Oct 2022
- Study completion4 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sorrento Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Royal, MD, Study director, Sorrento Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364840
- Sponsor's protocol ID
- MPR-COV-101AU
- Status last verified
- Jan 2023
- First submitted
- 15 Apr 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
PubMed 38181791
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05364840
- Acronym / sponsor ID
- MPR-COV-101AU
- Conditions
- COVID-19
- Keywords
- covid19, COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Sorrento Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 18 Oct 2022 (actual)
- Study completion
- 4 Nov 2022 (actual)
- First posted
- 6 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STI-1558 | Experimental | Drug: STI-1558Subjects 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 | Placebo comparator | Drug: PlaceboSubjects will receive placebo orally following either the SAD or MAD dosing schedule |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STI-1558Orally available protease inhibitor capsule | Drug | STI-1558 |
| PlaceboPlacebo product capsule | Drug | Placebo |
Primary outcome
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
Cardiac function (safety)
Time frame: baseline through study completion at up to 42 days
Heart function as assessed by 12-lead electrocardiogram
4 secondary outcomes
AUC of STI-1558 (PK)
Time frame: baseline through study completion at up to 42 days
Cmax of STI-1558
Time frame: baseline through study completion at up to 42 days
t1/2 of STI-1558
Time frame: baseline through study completion at up to 42 days
Tmax of STI-1558
Time frame: baseline through study completion at up to 42 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Derived from this study: PubMed 38181791Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Royal, MD study director
Sorrento Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STI-1558 in people with COVID-19, run by Sorrento Therapeutics, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (safety) (time frame: baseline through study completion at up to 42 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364840, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.