Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Subjects

NCT07277933 | Not Yet Recruiting Phase 1

• 1 other identifier: KHN702-30102
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose

  48 hours

Secondary Outcomes (6)

• Safety：Incidence and severity of Adverse Events( AE)/SAE

  from ICF signing date to day 7 since the first dose

• Cmax

  48 hours

• 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

  48 hours

Study Arms (2)

KHN702

EXPERIMENTAL

Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days.

Drug: KHN702

KHN702 placebo

PLACEBO COMPARATOR

Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days.

Drug: KHN702 placebo

Interventions

KHN702 DRUG

KHN702 tablet for oral administration

KHN702

KHN702 placebo DRUG

KHN702 placebo tablet for oral administration

KHN702 placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects between the ages of 18 and 75 years, inclusive.
• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive.
• Patients scheduled for surgery.
• According to the researcher's medical judgment, American Society of Anesthesiologists (ASA) classification≤Grade II.
• The subject can understand and comply with the study procedures and requirements, and can provide written informed consent prior to any study procedures.
• NRS ≥ 4 points within 6 hours after surgery.

You may not qualify if:

• 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:
• History of significant cardiovascular or cerebrovascular disease;
• Severe respiratory disease history;
• Severe Neurological and Psychiatric disease History;
• Active peptic ulcer disease, significant vomiting, chronic diarrhea, ileus, malabsorption, or other known conditions that significantly affect drug absorption, distribution, metabolism, or excretion;
• Subjects at high risk of bleeding who are deemed unsuitable for this trial by the investigator;
• 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.

Sponsors & Collaborators

• Chengdu Kanghong Pharmaceutical Group Co., Ltd.: lead

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mengchang Yang, Medical Doctor

CONTACT

86-28-87393401; ymc681@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2025
• First Posted: December 11, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11