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The purpose of this study is to assess safety, PK, Pharmacodynamic profile of a single dose of HRS-3095 in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-3095 single dose Dose level 1 | Experimental | Single dose HRS-3095 /placebo given orally |
|
| HRS-3095 single dose Dose level 2 | Experimental | Single dose HRS-3095 /placebo given orally |
|
| HRS-3095 single dose Dose level 3 | Experimental | Single dose HRS-3095 /placebo given orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-3095 | Drug | Single dose HRS-3095 /placebo given orally - Dose level 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Number of participants with Adverse events and Serious adverse events | Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Cmax | Maximum observed plasma concentration (Cmax) | Day 4 |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - AU0-inf |
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Main inclusion criteria
Main exclusion Criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathy You | Contact | +61 02 9299 0433 | kathyyou@atridia.com | |
| Eimy Minowa | Contact | +61 432223162 | eimy.minowa@atridia.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Bayswater | Victoria | 3153 | Australia |
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| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| ID | Term |
|---|---|
| D014581 | Urticaria |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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HRS-3095 or matching placebo given orally
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| HRS-3095 | Drug | Single dose HRS-3095 /placebo given orally - Dose level 2 |
|
| HRS-3095 | Drug | Single dose HRS-3095 /placebo given orally - Dose level 3 |
|
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀0-inf)
| Day 4 |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - Tmax | Time to reach maximum observed plasma concentration (Tmax) | Day 4 |
| PK Profile of HRS-3095 After a Single-Dose Administration, Pharmacokinetics - t½ | Terminal elimination half-life (t1/2) | Day 4 |
| PD Profile of HRS-3095 After a Single dose administration: | Target occupancy assessment | Day 8 |
| D006969 |
| Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |