Phase I, randomized, double-blind, comparator-controlled study to assess the safety, PK, and efficacy of single postsurgical application of HR18034 compared with Naropin®
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
64
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGNumber of SAEs and treatment-related severe AEs
Safety and tolerability:
Time frame: 14 days
Pain intensity assessed using an 11-point NPRS ranging
11-point Numercal Pain Rating Scale ranging from a score of 0 to 10. Pain-free defined as an NPRS of 0 or 1. Worst imaginable pain defined as an NPRS of 10
Time frame: Baseline till 168 hours post IP administration
AUC of NPRS
AUC of NPRS for time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Time frame: For time periods 0-12, 0-24, 0-36, 0-48, 0-72, and 0-96 hours
Patient Global Assessment of the method of pain control
Patient Global Assessment ranging from a score of 0 to 10. Satisfaction defined as a scale of 10, dissatisfaction defined as a scale of 0.
Time frame: 24 hours post IP administration till 168 hours post IP administration
Proportion of pain-free subjects at scheduled timepoints.
Pain-free defined as an NPRS of 0 or 1
Time frame: Baseline till 168 hours post IP administration
Proportion of subjects who used no rescue opioid analgesic
Proportion of subjects who used no rescue opioid analgesic
Time frame: Baseline till 168 hours post IP administration
Average daily rescue analgesic consumption
Average daily rescue analgesic consumption through 24, 48, 72 and 96 hours
Time frame: Baseline till 168 hours post IP administration
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Time to the first postoperative use of rescue opioid analgesics
Time to the first postoperative use of rescue opioid analgesics
Time frame: Baseline till 168 hours post IP administration
PK Cmax
Maximum blood concentration (Cmax)
Time frame: Baseline till 168 hours post IP administration
Wound assessment by Wound healing and status score
The surgical site will be examined by the investigator using Wound healing and status score. Wound healing and status score ranging from a score of 0 to 4,Good defined as a scale of 0. Worst defined as a scale of 4.
Time frame: Day 1 through Day 14
PK AUC
Area under the blood concentration-time curve (AUC)
Time frame: Baseline till 168 hours post IP administration