Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-2129 in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-2129 experimental group | Experimental |
| |
| HRS-2129 placebo group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-2129 | Drug | HRS-2129. |
| |
| HRS-2129 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence and severity of adverse events (AEs) | From ICF signing date to Day 39. | |
| The incidence and severity of adverse events (AEs) | From ICF signing date to Day 41. |
| Measure | Description | Time Frame |
|---|---|---|
| Cold Pain detection threshold for the Thermode Cold Test | Day 1 to Day 12. | |
| Cold Pain detection threshold for the Thermode Cold Test | Day 1 to Day 15. | |
| Heat Pain detection threshold for the Thermode Heat Test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | 410013 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
HRS-2129 placebo. |
|
| Day 1 to Day 12. |
| Heat Pain detection threshold for the Thermode Heat Test | Day 1 to Day 15. |
| Pain tolerance time for the Cold Pain Test | Day 1 to Day 12. |
| Pain tolerance time for the Cold Pain Test | Day 1 to Day 15. |
| Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | From ICF signing date to Day 13. |
| Number of participants with clinically meaningful findings in Columbia Suicide Severity Rating Scale (C-SSRS) Responses | From ICF signing date to Day 15. |
| Time to reach maximum plasma concentration (Tmax) of HRS-2129 | 0 hour to 216 hours after administration. |
| Terminal half-life (t1/2) | 0 hour to 216 hours after administration. |
| Maximum plasma concentration (Cmax) of HRS-2129 | 0 hour to 216 hours after administration. |
| Apparent clearance (CL/F) of HRS-2129 | 0 hour to 216 hours after administration. |
| Apparent volume of distribution (Vz/F) of HRS-2129 | 0 hour to 216 hours after administration. |