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Study was determined not to initiate.
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Indication : Treatment of Subject with COVID-19 infection Phase : Phase I Duration of Study : 12 day Sample size : at least 15 subjects Methodology : Classical 3+3 design Investigational Product : MPT0B640, 15, 30, 60, 80 and 100mg, oral suspension Study Objective
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MPT0B640 | Other | There is single Arm in this clinical trials. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MPT0B640 | Drug | Each dose of MPT0B640 will be administrated per Cohort. (15, 30, 60, 80, 100 mg of MPT0B640) |
|
| Measure | Description | Time Frame |
|---|---|---|
| MTD | MTD is defined as highest dose level in which 6 subjects have been treated with less than 2 instances of DLT. DLT assessed during the study treatment period (28 Âą 2 days) refers to a medically significant event which meets one of the criteria using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. | 28days(+/-2days) |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Viral load change (log10 viral load assessed by reverse transcription-qPCR) | Time Frame: Day 1, 3, 5, 7, 9 and 12 |
| Time to clinical improvement | Assessed TTCI with WHO clinical progression scale by measuring clinical status daily. TTCI is defined as the time (in days) from initiation of study treatment until a decline of one category on WHO clinical progression scale which ranges from 0 (uninfected; no viral RNA detected) to 10 (death) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) | Cmax | Day 1,3 and 5. |
| Pharmacokinetic (PK) | Ctrough | Day 1,3 and 5. |
Inclusion Criteria:
Subjects must meet all inclusion criteria as listed below:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ethan Seah | J Ints Bio | Study Director |
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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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Classical 3+3 design to determine MTD.
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| Time Frame: dialy up to Day 10 |
| Pharmacokinetic (PK) | AUCĪ | Day 1,3 and 5. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |