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
This is a multicenter, randomized, double-blind, placebo-controlled, two-stage phase II clinical study. The main objective is to evaluate the efficacy and safety of HSK21542 injection and explore the recommended dose and administration frequency for subsequent Phase II studies in conjunction with the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stage I:HSK21542 0.4 μg/kg | Experimental | Preoperative:0.4 μg/kg Postoperative:0.2 μg/kg; intravenous injection |
|
| stage I:HSK21542 1 μg/kg | Experimental | Preoperative:1 μg/kg Postoperative:0.5 μg/kg;intravenous injection |
|
| stage I:HSK21542 0.5μg/kg | Experimental | Postoperative: 0.5μg/kg;intravenous injection |
|
| stage I:HSK21542 1μg/kg | Experimental | Postoperative: 1μg/kg;intravenous injection |
|
| stage II:HSK21542 0.5μg/kg | Experimental | Postoperative: 0.5μg/kg;intravenous injection |
|
| stage II:HSK21542 1μg/kg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: stage I:HSK21542 0.4 μg/kg | Drug | Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | The time-weighted SPID at rest within 0-24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of Pain Intensity Differences (SPID) | The time-weighted sum of pain intensity differences of the rest pain in each group within 0-12 h after the first postoperative dose | Frome administration until 24 hours after administration |
| Use of remedial analgesics |
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of allergy to opioids, such as urticaria, or allergic to the intraoperative anesthetics prescribed in the protocol;
History or evidence of any one of the following diseases prior to screening:
Any of the following airway management risks during screening:
In receipt of any of the following drugs or therapies during the screening period:
Laboratory test parameters meet one of the following criteria in the screening period and is confirmed by retests:
Without oxygen supplement during the screening period, the pulse oxygen saturation is < 92%;
During the screening period, the virological examination for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), treponema pallidum antibody, or human immunodeficiency virus (HIV) antibody is positive;
History of drug abuse, narcotics use and/or alcohol abuse within 3 months before screening. Alcohol abuse is defined as > 2 units of alcohol consumption per day (1 unit = 360 mL of beer containing 5% alcohol, 45 mL of liquor containing 40% alcohol, or 150 mL of wine);
Donated or lost ≥ 400 mL of blood within 3 months before screening;
Participated in any drug clinical trials within 3 months before screening (defined as the administration of the investigational product or placebo);
Women who are pregnant or breastfeeding; fertile women or men who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 month after the completion of the trial (including male subjects);
Subjects determined by the investigator to be unsuitable for participating in this clinical study for any other reason.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40776930 | Derived | Zhong Y, Wang H, Yan M, Yang M, Zhang J, Nan L, Wang Z, Yang J, Wu J, Guo Q, Hu X, Xu H, Xu Q, Wang D. Efficacy and safety of peripherally-restricted kappa-opioid receptor agonist-HSK21542 for postoperative analgesia in patients undergoing laparoscopic abdominal surgery: a randomized, placebo-controlled phase 2 trial. Front Med (Lausanne). 2025 Jul 24;12:1604790. doi: 10.3389/fmed.2025.1604790. eCollection 2025. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Postoperative: 1μg/kg;intravenous injection
|
| Postoperative: Placebo | Placebo Comparator | Placebo;intravenous injection |
|
| Experimental: stage I:HSK21542 1 μg/kg | Drug | Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations |
|
| Experimental: stage I:HSK21542 0.5μg/kg | Drug | once each at 0, 8, and 16 h postoperative, for a total of 3 administrations |
|
| Experimental: stage I:HSK21542 1μg/kg | Drug | once each at 0, 8, and 16 h postoperative, for a total of 3 administrations |
|
| Experimental: stage II:HSK21542 0.5μg/kg | Drug | once each at 0, 8, and 16 h postoperative, for a total of 3 administrations |
|
| Experimental: stage II:HSK21542 1μg/kg | Drug | once each at 0, 8, and 16 h postoperative, for a total of 3 administrations |
|
| Placebo | Drug | once each at 0, 8, and 16 h postoperative, for a total of 3 administrations |
|
Cumulative dose of remedial analgesics (mg of morphine injection) in each group within 0-12 h and 0-24 h after the first postoperative dose, the percentage of subjects in each group who have not used remedial analgesics, and the time to start using remedial analgesics |
| Frome administration until 24 hours after administration |
| Pain Intensity Differences(PID) | The PID at rest at each scoring time point after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| The proportion of subjects with a NRS of ≤ 3 | The proportion of subjects in each group with a resting pain NRS of ≤ 3 at 12 h and 24 h after the first postoperative dose | Frome administration until 24 hours after administration |
| Duration of analgesia | The duration of analgesia after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| Satisfaction scores on postoperative analgesia | Subject satisfaction score and investigator satisfaction score on postoperative analgesia at 24 h after the first postoperative administration in each group | Frome administration until 24 hours after administration |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided