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The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of single- and multiple-dose administration of S-892216-LAI in healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 (Single Ascending Dose) | Experimental | Participants will receive a single dose of S-892216-LAI or placebo on Day 1. |
|
| Part 2 (Multiple Ascending Dose) | Experimental | Participants will receive multiple doses of S-892216-LAI or placebo on Day 1 and Day 85 in treatment periods 1 and 2, respectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| S-892216-LAI | Drug | S-892216-LAI injection will be administered per schedule specified in the arm description. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part: Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Day 1 through Day 364 | |
| Part 2: Number of Participants With TEAEs | Day 1 through Day 448 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Maximum Plasma Concentration (Cmax) of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 | |
| Part 2: Cmax of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trials Administrator Clinical Support Help Line | Contact | 800-849-9707 | Shionogiclintrials-admin@shionogi.co.jp |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Clinical Research: Lenexa | Recruiting | Lenexa | Kansas | 66219 | United States | |
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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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| Placebo | Drug | Physiological saline will be administered per schedule specified in the arm description. |
|
| Part 1: Time to Reach Cmax (Tmax) of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 |
| Part 2: Tmax of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 |
| Part 1: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration After Dosing (AUC0-last) of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 364 |
| Part 2: AUC0-last of S-892216 and its Metabolites | Day 1 (pre-administration, up to 12 hours post-administration) through Day 70 in Treatment Period 1 and Day 85 (pre-administration, up to 12 hours post-administration) through Day 448 in Treatment Period 2 |
| ICON Clinical Research: Salt Lake City |
| Recruiting |
| Salt Lake City |
| Utah |
| 84124 |
| United States |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |