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This is a multi-center, randomized, two-stage, phase II clinical study .The main objective is to evaluate the safety and tolerability of HSK21542 injection for analgesia in patients undergoing colonoscopy, and, combining the pharmacodynamic (PD) and pharmacokinetic (PK) characteristics
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I: HSK21542 0.5 μg/kg | Experimental | intravenous injection |
|
| Stage I: HSK21542 1 μg/kg | Experimental | intravenous injection |
|
| Stage II : HSK21542 0.5 μg/kg | Experimental | intravenous injection |
|
| Stage II : HSK21542 1 μg/kg | Experimental | intravenous injection |
|
| Stage II : HSK21542 2 μg/kg | Experimental | intravenous injection |
|
| Stage II : placebo | Placebo Comparator | intravenous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stage I: HSK21542 0.5 μg/kg | Drug | intravenous injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| BPS-NI score>3 did not reach the proportion | the proportion of subjects with BPS-NI score>3 did not appear from the beginning of insertion of colonoscopy to the removal of colonoscopy | From administration until 24 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of occurrences of BPS-NI score of > 3 | The ratio of subjects with BPS-NI scores of > 3 for 0, 1, 2, 3, or more times from the insertion to the removal of colonoscope | From administration until 24 hours after administration |
| NRS score |
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Inclusion Criteria:
Exclusion Criteria:
Patients having contraindications to deep sedation/general anesthesia or a history of past sedation/anesthesia accidents;
Patients with past history of allergy or contraindications to opioids, their rescue medications, and propofol;
Medical history or evidence of any of the following prior to screening/at baseline, which may increase sedation/anesthesia risk:
Patients with the following airway management risks:
In receipt of any one of the following medications or treatments at screening:
Patient whose laboratory parameters measured at screening reach the following criteria and are verified through reexamination:
Having participated in other drug clinical trials within 3 months prior to screening (defined as having received investigational product or placebo);
Pregnant or breastfeeding females: women or men of child-bearing potential who are unwilling to use contraception during the trial; subjects who are planning pregnancy within 3 months after the trial (including male subjects);
Subject judged by the investigator to have any other factors unsuitable for involvement in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | China |
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Stage I is open-label,Stage II is double-blind
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| Stage I: HSK21542 1 μg/kg |
| Drug |
intravenous injection |
|
| HSK21542 0.5 μg/kg | Drug | intravenous injection |
|
| HSK21542 1 μg/kg | Drug | intravenous injection |
|
| HSK21542 2 μg/kg | Drug | intravenous injection |
|
| Placebo | Drug | intravenous injection |
|
NRS score of resting pain at each time point after the subject is fully awake
| From administration until 24 hours after administration |
| Dose of propofol used | The total dose used during the induction period, maintenance period, and the entire study process | From the first dose of the study drug to removal of colonoscope on day 1 |
| Success rate of colonoscopy diagnosis and treatment | The following two conditions must be met for successful diagnosis and treatment: complete colonoscopy diagnosis and treatment and failure to use remedial analgesics | From the first dose of the study drug to removal of colonoscope on day 1 |
| Time to full recovery | The time from the removal of colonoscope to when the subject opens his/her eyes and can tell his/her date of birth | On day 1 |
| Time to discharge | The time from the removal of colonoscope to the occurrence of 3 consecutive Aldrete score of ≥ 9 | On day 1 |
| The incidence and severity of AEs | Adverse event/serious adverse event | from signing the informed consent form to the follow-up period |
| 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 |
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