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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Kanghong Pharmaceutical Group Co., Ltd.

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 of significant cardiovascular or cerebrovascular disease;

Severe respiratory disease history;

Severe Neurological and Psychiatric disease History;

Trial design

Design model

Parallel

Treatments tested in this trial

  • KHN702

    Drug

    KHN702 tablet for oral administration

  • KHN702 placebo

    Drug

    KHN702 placebo tablet for oral administration

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: KHN702Experimental treatment 1 intervention
Group B: KHN702 placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
48 hours

Secondary outcomes

1

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

Time frame
from ICF signing date to day 7 since the first dose
2

Cmax

Maximum Plasma Concentration

Time frame
48 hours
3

Time-weighted the Sum of Pain Intensity Differences in Pain Score over Times

Time frame
48 hours
4

Times and Cumulative Amount of Rescue Analgesics Used by Subjects within 0 to 48 Hours after the First Dose.

Time frame
48 hours

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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