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This is a A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of a kappa receptor agonist HSK21542 in Healthy Volunteers.
The study will enroll approximately 50 adults. The anticipated study duration will be up to 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK21542 single ascending doses | Experimental |
| |
| Placebo single dose | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK21542 | Drug | Single dose, injection, starting dose of 0.2ug escalating up to 20ug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of adverse events | Between screening and 7-9 days after dosing |
| Number of subjects with abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters | To evaluate the safety and tolerability of HSK21542 in comparison with placebo after a single injection in healthy subjects in terms of abnormal physical examination/ abnormal vital signs/ abnormal laboratory parameters | Between screening and 7-9 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum (peak) plasma drug concentration | From the start of administration to 24 hours after administration |
| Tmax | Time to reach maximum (peak) plasma concentration following drug administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul Wabnitz, PhD | CMAX Clinical Research Pty Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CMAX Clinical Research Pty Ltd | Adelaide | Australia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059350 | Chronic Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| Placebo | Drug | Single dose, injection matching placebo |
|
| From the start of administration to 24 hours after administration |
| t1/2 | Elimination half-life | From the start of administration to 24 hours after administration |
| AUC0-t | Area under the plasma concentration-time curve from time zero to time t. | From the start of administration to 24 hours after administration |
| AUC0-inf | Area under the plasma concentration-time curve from time zero to infinity | From the start of administration to 24 hours after administration |
| CL | Apparent total body clearance of the drug from plasma | From the start of administration to 24 hours after administration |
| Vd | Apparent volume of distribution | From the start of administration to 24 hours after administration |
| D012816 | Signs and Symptoms |