Postoperative PainPhase 1NCT07277933
Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Subjects
A Phase 1 study testing KHN702 in people with Postoperative Pain, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- KHN702
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Feb 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Patients: A Randomized, Double-blind, Placebo-Controlled, Phase Ib Trial
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
- Being tested
- KHN702, KHN702 placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KHN702Drug
KHN702 tablet for oral administration
KHN702 placeboDrug
KHN702 placebo tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| KHN702 | Experimental | Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days. Receives: 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. Receives: Drug: KHN702 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose
Measured: 48 hours
Secondary outcomes (6)
Safety：Incidence and severity of Adverse Events( AE)/SAE
Measured: from ICF signing date to day 7 since the first dose
Cmax
Maximum Plasma Concentration
Measured: 48 hours
Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times
Measured: 48 hours
Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose.
Measured: 48 hours
Tmax
Time to Maximum Plasma Concentration
Measured: 48 hours
AUC0-t
Area Under the concentration-time curve from zero to t
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277933
- Sponsor's protocol ID
- KHN702-30102
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of KHN702 Tablets in Moderate to Severe Post-operative Pain Patients: A Randomized, Double-blind, Placebo-Controlled, Phase Ib Trial
- ClinicalTrials.gov ID
- NCT07277933
- Acronym / sponsor ID
- KHN702-30102
- Conditions
- Postoperative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chengdu Kanghong Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KHN702 | Experimental | Drug: KHN702Participants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days. |
| KHN702 placebo | Placebo comparator | Drug: KHN702 placeboParticipants will be randomized to either the KHN702 tablet or placebo group, and administer study drug for 2 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KHN702KHN702 tablet for oral administration | Drug | KHN702 |
| KHN702 placeboKHN702 placebo tablet for oral administration | Drug | KHN702 placebo |
Primary outcome
Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose
Time frame: 48 hours
6 secondary outcomes
Safety：Incidence and severity of Adverse Events( AE)/SAE
Time frame: from ICF signing date to day 7 since the first dose
Cmax
Time frame: 48 hours
Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times
Time frame: 48 hours
Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose.
Time frame: 48 hours
Tmax
Time frame: 48 hours
AUC0-t
Time frame: 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KHN702 in people with Postoperative Pain, run by Chengdu Kanghong Pharmaceutical Group Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mengchang Yang, Medical Doctor (86-28-87393401, ymc681@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-weighted the Sum of Pain Intensity Differences in Pain Score 0 to 48 hours after the first dose (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.