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This is double-blind,randomized, single and multiple dose trial to evaluate the pharmacokinetics(PK), safety, tolerability and drug-drug interaction of RAY1216, and the effect of food on RAY1216 Pharmacokinetics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RAY1216 dose 1 | Experimental | SAD |
|
| RAY1216 dose 2 | Experimental | SAD |
|
| RAY1216 dose 3 | Experimental | SAD |
|
| RAY1216 dose 4(DDI) | Experimental | drug-drug interaction |
|
| RAY1216 dose 5 | Experimental | MAD |
|
| RAY1216 dose 6 | Experimental | MAD |
|
| RAY1216 dose 7 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAY1216 dose 1 | Drug | RAY1216 dose 1 or Placebo |
| |
| RAY1216 dose 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in single ascending dose | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Day 1 to Day 5 |
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in multiple ascending dose | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Day 1 to Day 9 |
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in DDI part | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Day 1 to Day 15 |
| Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE) in food effect part | A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported | Day 1 to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of food on the PK of RAY1216 single dose(Cmax) | Day 1 to Day 21 | |
| To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(Cmax) | Day 1 to Day 15 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Jilin City | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39887246 | Derived | Hu Y, Li H, Wang K, Wu D, Zhang H, Ding Y, Wu J, Ye S, Peng Y, Liu L. Single- and multiple-dose pharmacokinetics and safety of the SARS-CoV-2 3CL protease inhibitor RAY1216: a phase 1 study in healthy participants. Antimicrob Agents Chemother. 2025 Mar 5;69(3):e0145024. doi: 10.1128/aac.01450-24. Epub 2025 Jan 31. |
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MAD |
|
| RAY1216 dose 8 | Experimental | MAD |
|
| RAY1216 dose 9(food effect) | Experimental | food effect on single dose |
|
| RAY1216 dose 10(food effect) | Experimental | food effect on single dose |
|
| Drug |
RAY1216 dose 2 or Placebo |
|
| RAY1216 dose 3 | Drug | RAY1216 dose 3 or Placebo |
|
| RAY1216 dose 4 &ritonavir | Drug | RAY1216 dose 4 &ritonavir or Placebo |
|
| RAY1216 dose 5 | Drug | RAY1216 dose 5 or Placebo |
|
| RAY1216 dose 6 | Drug | RAY1216 dose 6 or Placebo |
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| RAY1216 dose 7 | Drug | RAY1216 dose 7 or Placebo |
|
| RAY1216 dose 8 | Drug | RAY1216 dose 8 or Placebo |
|
| RAY1216 dose 9 | Drug | RAY1216 dose 9 or Placebo with high fat meal |
|
| RAY1216 dose 10 | Drug | RAY1216 dose 10 or Placebo with high fat meal |
|
| To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmax) |
| Day 1 to Day 9 |
| To determine the effect of food on the PK of RAY1216 single dose(AUC0-∞) | Day 1 to Day 21 |
| To investigate the effect of Ritonavir on the pharmacokinetics of RAY1216(AUC0-∞) | Day 1 to Day 15 |
| To determine the single and multiple oral dose pharmacokinetic profiles of RAY1216(Cmin) | Day 1 to Day 9 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019438 | Ritonavir |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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