COVID-19Phase 1NCT05817708
A Study of Silmitasertib (CX-4945) in Healthy Subject
A Phase 1 study testing CX-4945 in people with COVID-19, run by Senhwa Biosciences, Inc. at 1 site in Taiwan.
Trial summary
This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- CX-4945
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Nov 2022to 20 Jun 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects 20to 55 years of age, inclusive, at screening
- Body mass index (BMI)within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
- Subjects who are of reproductive potential agreed to remain abstinent or use (or have their partner use) an acceptable method of birth control (intrauterine device, hormonal contraception, vasectomy or condom) from screening until at least 2 weeks after the last study drug administration.
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
- Subject with acceptable hematology, biochemistry and urinalysis during screening period.
- Subject is willing and able to comply with study procedures and sign informed consent.
Who cannot join
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and from screening until at least 2 weeks after the last study drug administration. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
- Active or uncontrolled infections such asCOVID-19, HIV or with serious illnesses or medical conditions which would not permit the subject to receive study treatment.
- Subject has received any prescription of drug within 3 days prior to study enrollment.
- Subject has drug abuse history.
- Any active or recurring clinically significant hepatic disease including HBV and HCV.
- Subject has received any investigational agent within 28 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product.
- Any other medical reason as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Dose Selection Phase 1 Study Evaluating the Safety and Tolerability of Silmitasertib
This is a Phase I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.
Read the detailed description
COVID-19 is characterized by SARS-CoV-2 induced up-regulation of host protein kinase CK2 that catalyzes phosphorylation of many proteins, modulating their activities in cellular processes. CX-4945 demonstrated anti-viral efficacy in COVID-19 in vitro studies. In CX4945-AV01-IIT(IND 152726), CX-4945 was a safe treatment at 1000 mg BID regimen supported by the fact of no occurrence of treatment related Grade ≥ 3 AE, death or SUSAR. There were approximately 50 % of patients who experienced gastrointestinal disorders of grade 1-2. In CX4945-AV01-IIT, an out-patient study, there were 50% experienced gastrointestinal disorders. To further evaluate the safety and tolerability of CX-4945, this phase 1 study will use lower doses and subjects will be close-monitored to evaluate the safety.
- Conditions
- COVID-19
- Being tested
- CX-4945
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CX-4945Drug
Also called Silmitasertib
Drug: CX-4945
Silmitasertib, orally, once or twice daily for 5 days.
Other Name: Silmitasertib
| Study group | Role | What they receive |
|---|---|---|
| CX-4945 200mg QD | Experimental | CX-4945 will be administered at 200mg QD for continuously 5 days. Receives: Drug: CX-4945 |
| CX-4945 200mg BID | Experimental | CX-4945 will be administered at 200mg BID for continuously 5 days. Receives: Drug: CX-4945 |
| CX-4945 400mg BID | Experimental | CX-4945 will be administered at 400mg BID for continuously 5 days. Receives: Drug: CX-4945 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAT)
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity [as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 5.0], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
Measured: Day 1 to Day 5
Secondary outcomes (7)
Evaluate Changes in Blood Chemistry.
Changes ALP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
Evaluate Changes in Blood Chemistry.
Changes AST in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Changes ALT in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Changes LDH in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Changes CPK in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Changes CRP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning.
Measured: Day 1 to Day 6
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
ECG assessments were done during Screening, Day 1, Day 3, Day 5, and Day 6. A 12-lead ECG was performed at baseline (Day1), Day 3, Day 5, and Day 6 and categorized as normal, abnormal and not clinically significant (abnormal NCS) or abnormal and clinically significant (abnormal CS).
Measured: Screening, Day 1, Day 3, Day 5, and Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start28 Nov 2022
- Primary completion23 Mar 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senhwa Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jin-Ding Huang, PhD, Study director, Senhwa Biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817708
- Sponsor's protocol ID
- CX4945-AV04-phase I
- Status last verified
- Dec 2024
- First submitted
- 30 Jan 2023
- Last updated
- 27 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose Selection Phase 1 Study Evaluating the Safety and Tolerability of Silmitasertib
- ClinicalTrials.gov ID
- NCT05817708
- Acronym / sponsor ID
- CX4945-AV04-phase I
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Senhwa Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Posted 27 Jan 2025
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 I single center, open-label, parallel design in 30 subjects to evaluate safety and tolerability of CX-4945 200mg QD, 200 mg BID and 400mg BID doses (10 subjects in each regimen) for continuously 5 days in healthy subjects for dose selection.
Detailed description
COVID-19 is characterized by SARS-CoV-2 induced up-regulation of host protein kinase CK2 that catalyzes phosphorylation of many proteins, modulating their activities in cellular processes. CX-4945 demonstrated anti-viral efficacy in COVID-19 in vitro studies. In CX4945-AV01-IIT(IND 152726), CX-4945 was a safe treatment at 1000 mg BID regimen supported by the fact of no occurrence of treatment related Grade ≥ 3 AE, death or SUSAR. There were approximately 50 % of patients who experienced gastrointestinal disorders of grade 1-2. In CX4945-AV01-IIT, an out-patient study, there were 50% experienced gastrointestinal disorders. To further evaluate the safety and tolerability of CX-4945, this phase 1 study will use lower doses and subjects will be close-monitored to evaluate the safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CX-4945 200mg QD | Experimental | Drug: CX-4945CX-4945 will be administered at 200mg QD for continuously 5 days. |
| CX-4945 200mg BID | Experimental | Drug: CX-4945CX-4945 will be administered at 200mg BID for continuously 5 days. |
| CX-4945 400mg BID | Experimental | Drug: CX-4945CX-4945 will be administered at 400mg BID for continuously 5 days. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy male and female subjects 20to 55 years of age, inclusive, at screening
- Body mass index (BMI)within the range of 18.0 to 30.0 kg/m2, inclusive, and a minimum weight of 50.0 kg at screening
- Subjects who are of reproductive potential agreed to remain abstinent or use (or have their partner use) an acceptable method of birth control (intrauterine device, hormonal contraception, vasectomy or condom) from screening until at least 2 weeks after the last study drug administration.
- Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, and electrocardiogram;
- Subject with acceptable hematology, biochemistry and urinalysis during screening period.
Key exclusion criteria (7 listed)
- Pregnant or nursing women. NOTE: Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study entry and from screening until at least 2 weeks after the last study drug administration. Should a man father a child, or a woman become pregnant or suspect she is pregnant while participating in this study, he or she should inform the treating physician immediately.
- Active or uncontrolled infections such asCOVID-19, HIV or with serious illnesses or medical conditions which would not permit the subject to receive study treatment.
- Subject has received any prescription of drug within 3 days prior to study enrollment.
- Subject has drug abuse history.
- Any active or recurring clinically significant hepatic disease including HBV and HCV.
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 |
|---|---|---|
| CX-4945Also: SilmitasertibDrug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib | Drug | CX-4945 200mg BID, CX-4945 200mg QD, CX-4945 400mg BID |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAT)
Time frame: Day 1 to Day 5
Evaluate the number adverse events occurring from Day 1 to Day 5 as characterized by type, frequency, severity [as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [CTCAE] version 5.0], timing, seriousness, and relationship to study therapy after administration of 200mg QD, 200mg BID and 400mg BID for continuously 5 days to healthy subjects.
7 secondary outcomes
Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
To Evaluate Changes in Blood Chemistry.
Time frame: Day 1 to Day 6
Number of Participants Evaluated as Having Abnormalities (CS or NCS) in Their ECG
Time frame: Screening, Day 1, Day 3, Day 5, and Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jin-Ding Huang, PhD study director
Senhwa Biosciences
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 CX-4945 in people with COVID-19, run by Senhwa Biosciences, Inc. at 1 site in Taiwan.
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 6 inclusion and 7 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 27 Jan 2025. 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 Taiwan. 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. 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?
Yes. Results are posted in the registry (first posted 27 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Treatment-emergent Adverse Events (TEAT) (time frame: Day 1 to Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2025.