Phase I clinical trial evaluating the safety, tolerance, pharmacokinetics and pharmacodynamics of HSK21542 injection in healthy volunteers.
Rong Shao, Hai-Ying Wang, Zou-Rong Ruan...
https://pubmed.ncbi.nlm.nih.gov/39397291Actively Recruiting
Led by Peking University First Hospital · Updated on 2026-04-24
140
Participants Needed
1
Research Sites
4 weeks
Total Duration
Researchers are evaluating the use of anrikefon, a new type of pain medicine that targets specific receptors related to visceral pain, for managing pain after laparoscopic surgery. This study focuses on patients undergoing laparoscopic colorectal surgery, aiming to find the best dose of anrikefon given through a patient-controlled intravenous analgesia (PCIA) pump. The goal is to specifically reduce visceral pain, which is often underestimated and not well controlled by usual pain medicines like morphine. Participants will receive postoperative pain management with one of four treatments: high-dose anrikefon, medium-dose anrikefon, low-dose anrikefon, or morphine. Each treatment is delivered via a PCIA pump programmed to give an initial dose followed by patient-controlled bolus doses with a lockout period, over 48 hours. The treatments are combined with other pain control methods like nerve blocks for somatic pain and nonsteroidal anti-inflammatory drugs (NSAIDs) for inflammatory pain as part of a multimodal approach. During the study, participants will be monitored closely for pain levels at rest and with movement over 48 hours after surgery using pain intensity measures. Researchers will assess the area under the curve (AUC) of visceral and overall pain to evaluate effectiveness. Safety and side effects will also be observed. The study is designed as a randomized, double-blind, active-controlled trial, helping determine the feasibility of a larger future study and optimal dosing for anrikefon in this setting.
CONDITIONS
Anrikefon-based Patient-controlled Intravenous Analgesia Following Laparoscopic Surgery
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 hours
Participants receive patient-controlled intravenous analgesia with anrikefon or morphine following laparoscopic surgery to manage postoperative pain.
1 baseline visit and continuous use of analgesic pump for 48 hours
Total: 1 location
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
D
Dong-Xin Wang, MD, PhD
C
Chun-Qing Li, MD
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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