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This study is a randomized, double-blind, placebo-controlled, parallel-group clinical trial. To preliminarily evaluate the safety and efficacy of KHN702 tablets in moderate to severe post-operative pain patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHN702 | Experimental | Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days. |
|
| KHN702 placebo | Placebo Comparator | Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHN702 | Drug | KHN702 tablet for oral administration |
| |
| KHN702 placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Safety:Incidence and severity of Adverse Events( AE)/SAE | from ICF signing date to day 7 since the first dose | |
| Cmax | Maximum Plasma Concentration | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
Participants experiencing acute or chronic pain unrelated to the surgical site, which the investigator deems may confound the participant's assessment of postoperative pain.
History or evidence of any of the following conditions prior to screening:
Long-term use of opioids or nonsteroidal anti-inflammatory drugs within the past 30 days prior to screening, or discontinuation of medications affecting analgesic efficacy assessment (except those permitted by the protocol) less than 5 half-life prior to randomization.
Subjects with a history of opioid allergy, or those with a history of allergy to the intraoperative medications specified in the protocol, postoperative rescue analgesics, or known allergies to the investigational drug or its excipients.
Subjects who underwent major surgery within 3 months prior to screening and the investigator determined that it would affect postoperative pain assessment.
Any of the following infectious diseases were present during screening: Hepatitis B surface antigen (HBsAg) positive, hepatitis C virus antibody (HCV Ab) positive, human immunodeficiency virus antibody (HIV Ab) positive, or serum treponema pallidum antibody (TPAb) positive.
History of substance abuse or alcohol abuse within the three months prior to screening .
History of blood donation within the past three months prior to screening.
Individuals who have participated in any clinical research within the past three months prior to screening .
Pregnant or lactating women; women or men of reproductive potential who are unwilling to use contraception throughout the study period; or subjects (including male subjects) planning to conceive within 3 months after study completion.
Subjects with intraoperative blood loss exceeding 1000 mL or those experiencing other severe complications during surgery;
Subjects requiring intensive care following surgery;
Other circumstances deemed unsuitable for participation in this trial by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mengchang Yang, Medical Doctor | Contact | 86-28-87393401 | ymc681@126.com |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Drug |
KHN702 placebo tablet for oral administration |
|
| Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times | 48 hours |
| Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose. | 48 hours |
| Tmax | Time to Maximum Plasma Concentration | 48 hours |
| AUC0-t | Area Under the concentration-time curve from zero to t | 48 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |