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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CX-4945 200mg QD | Experimental | CX-4945 will be administered at 200mg QD for continuously 5 days. |
|
| CX-4945 200mg BID | Experimental | CX-4945 will be administered at 200mg BID for continuously 5 days. |
|
| CX-4945 400mg BID | Experimental | CX-4945 will be administered at 400mg BID for continuously 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CX-4945 | Drug | Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 to Day 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Changes in Blood Chemistry. | Changes ALP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 1 to Day 6 |
| Evaluate Changes in Blood Chemistry. | Changes AST in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin-Ding Huang, PhD | Senhwa Biosciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Taipei | 110301 | Taiwan |
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30 enrolled participants met inclusion criteria and were randomized.
Participants were recruited from healthy subjects at Taipei Medical University Hospital between November 2022 and December 2022. The first participant was enrolled on November 28th, 2022, and the last was enrolled in 28th December 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | CX-4945 200mg QD | CX-4945 will be administered at 200mg QD for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
| FG001 | CX-4945 200mg BID | CX-4945 will be administered at 200mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
| FG002 | CX-4945 400mg BID | CX-4945 will be administered at 400mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
[Not Specified]
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| ID | Title | Description |
|---|---|---|
| BG000 | CX-4945 200mg QD | CX-4945 was administered at 200mg QD for continuously 5 days. |
| BG001 | CX-4945 200mg BID | CX-4945 was administered at 200mg BID for continuously 5 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Treatment-Emergent Adverse Events | Posted | Count of Participants | Participants | Day 1 to Day 5 |
|
from Day 1 to Day 6
Adverse Events experienced by patients from randomization(Day 1) to Day 6 (including vital signs, physical findings, clinical laboratory, and ECG results) as characterized by type, frequency, severity (as graded by Common Terminology Criteria for Adverse Events (CTCAE version 5.0), timing, seriousness, and relationship to study therapy.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CX-4945 200mg BID | CX-4945 will be administered at 200mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dirrhoea | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gina Huang | Senhwa Biosciences, Inc. | +886-2-89119856 | 111 | ginahuang@senhwabio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 30, 2022 | Sep 20, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 5, 2023 | Sep 20, 2024 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C555142 | silmitasertib |
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|
| 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. | 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. | 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. | 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. | 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). | Screening, Day 1, Day 3, Day 5, and Day 6 |
| BG002 | CX-4945 400mg BID | CX-4945 was administered at 400mg BID for continuously 5 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| CX-4945 200mg BID |
CX-4945 will be administered at 200mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
| OG002 | CX-4945 400mg BID | CX-4945 will be administered at 400mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib |
|
|
| Secondary | Evaluate Changes in Blood Chemistry. | Changes ALP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | U/L | Day 1 to Day 6 |
|
|
|
| Secondary | Evaluate Changes in Blood Chemistry. | Changes AST in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | U/L | Day 1 to Day 6 |
|
|
|
| Secondary | To Evaluate Changes in Blood Chemistry. | Changes ALT in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | U/L | Day 1 to Day 6 |
|
|
|
| Secondary | To Evaluate Changes in Blood Chemistry. | Changes LDH in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | U/L | Day 1 to Day 6 |
|
|
|
| Secondary | To Evaluate Changes in Blood Chemistry. | Changes CPK in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | U/L | Day 1 to Day 6 |
|
|
|
| Secondary | To Evaluate Changes in Blood Chemistry. | Changes CRP in blood chemistry assessment from Day 1(Baseline) to Day 6 morning. | Day 6 (EOT) - Change from Baseline | Posted | Mean | Standard Deviation | mg/dL | Day 1 to Day 6 |
|
|
|
| Secondary | 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). | [Not Specified] | Posted | Count of Participants | Participants | Screening, Day 1, Day 3, Day 5, and Day 6 |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | CX-4945 200mg QD | CX-4945 will be administered at 200mg QD for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib | 0 | 10 | 0 | 10 | 3 | 10 |
| EG002 | CX-4945 400mg BID | CX-4945 will be administered at 400mg BID for continuously 5 days. CX-4945: Drug: CX-4945 Silmitasertib, orally, once or twice daily for 5 days. Other Name: Silmitasertib | 0 | 10 | 0 | 10 | 7 | 10 |
| Nausea | Gastrointestinal disorders | MedDRA (25.1) | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
|
| C-reactive protein abnormal | Investigations | MedDRA (25.1) | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA (25.1) | Non-systematic Assessment |
|
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA (25.1) | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
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| Day 3 |
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| Day 5 |
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| Day 6 |
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