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A study to evaluate safety, tolerability and pharmacokinetics of QLS1128 sustained-release tablets and in combination with ritonavir tablets in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS1128 A-Dose 1~5 | Experimental | single dose |
|
| QLS1128 C-Dose 1~3 | Experimental | Twice daily for 7 days |
|
| QLS1128 D-Dose 1 | Experimental | fasting,high fat meal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS1128 A-Dose 1~5 and Ritonavir | Drug | Cohort 1: QLS1128 A-Dose 1 or Placebo Cohort 2: Period 1: QLS1128 A-Dose 2 or Placebo, on day 1. Period 2:QLS1128 A-Dose 2 or Placebo with high fat meal on day 5. Period 3:QLS1128 A-Dose 2 or Placebo plus Ritonavir on day 9 Cohort 3: QLS1128 A-Dose 3 or Placebo Cohort 4: QLS1128 A-Dose 4 or Placebo Cohort 5: QLS1128 A-Dose 5 or Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The Adverse events of QLS1128 | Adverse events, including type, incidence, grade (determined with reference to NCI-CTCAE V5.0) | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| The PK parameters of QLS1128 | Estimate of steady state Cmax for single dose administration of QLS1128 | Day 1 to Day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| The PK parameters of QLS1128 | Estimate of steady state AUC0-t for single dose administration of QLS1128 | Day 1 to Day 3 |
| The PK parameters of QLS1128 | Estimate of steady state Cmax for multiple dose administration of QLS1128 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yunfei ju, M.D. | Contact | 15053185458 | yunfei.ju@qilu-pharma.com |
| Name | Affiliation | Role |
|---|---|---|
| yunfei ju, M.D. | Qilu Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Pharmaceutical Co., Ltd. | Recruiting | Jinan | Shandong | 10000 | China |
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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 |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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|
| QLS1128 C-Dose 1~3 and Ritonavir | Drug | Cohort 6: Period 1: QLS1128 C-Dose 1 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 1 or Placebo plus Ritonavir , twice daily for 7 days Cohort 7: Period 1: QLS1128 C-Dose 2 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 2 or Placebo plus Ritonavir , twice daily for 7 days Cohort 8: Period 1: QLS1128 C-Dose 3 or Placebo, twice daily for 7 days. Period 2:QLS1128 C-Dose 3 or Placebo plus Ritonavir , twice daily for 7 days |
|
| QLS1128 D-Dose 1 and Ritonavir | Drug | Cohort 9: Group A:QLS1128 D-Dose 1 plus Ritonavir under fasting condition, on day 1. QLS1128 D-Dose 1 plus Ritonavir under fatty food condition, on day 5 Group B: QLS1128 D-Dose 1 plus Ritonavir under fatty food condition , on day 1. QLS1128 D-Dose 1 plus Ritonavir under fasting condition, on day 5 |
|
| Day 1 up to Day 7 |
| The PK parameters of QLS1128 | Estimate of steady state AUC0-t for multiple dose administration of QLS1128 | Day 1 up to Day 7 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |