A Trial of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

A Phase II, Multicenter, Randomized, Single-Blind, Dose Exploration, Positive Comparator Study to Evaluate the Efficacy and Safety of Tegileridine Fumarate Lnjection for Prolonged Mechanical Ventilation Abirritation in the Intensive Care Unit (ICU)

The purpose of this study is to evaluate the efficacy and safety of Tegileridine Fumarate lnjection for prolonged abirritation(48h to 72h) during mechanical ventilation in the ICU.

Study Overview

• Status: Recruiting
• Conditions: Abirritation in the ICU
• Intervention / Treatment: Drug: Tegileridine Fumarate lnjection; Drug: Tegileridine Fumarate lnjection; Drug: Remifentanil Hydrochloride for Injection

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lei Tang; Phone Number: +0518-82342973; Email: ei.tang.lt31@hengrui.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Recruiting
      • Zhongshan Hospital
      • Principal Investigator: Ming Zhong
  • Wuhan
    • Hubei, Wuhan, China, 430015
      • Recruiting
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Principal Investigator: You Shang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients or their guardians are able to provide a written informed consent
2. Subjects have been treated with endotracheal intubation and mechanical ventilation ≤24h, and then prolonged mechanical ventilation ≥48h in the next
3. Age ≥ 18 and ≤ 85 years, Male or female
4. Body mass index (BMI) > 18 and < 30 kg/m2
5. Use of highly effective contraception for a specified period if applicable

Exclusion Criteria:

1. Those who are known or suspected to be allergic or contraindicated to various components of the experimental drugs involved in the research institute
2. With an expected survival time of less than 48 hours
3. unable to undergo CPOT and RASS assessments due to various reasons, such as a history of psychiatric disorders, neurological disorders, neurological dysfunction, and consciousness disorders, as well as blindness, deafness, or aphasia
4. Myasthenia gravis, bronchial asthma attack, acute intestinal obstruction, abdominal compartment syndrome
5. Multiple organ failure
6. Malignant tumor Subjects who received radiotherapy, chemotherapy, targeted therapy, and immunotherapy within the first month of randomization
7. Chronic pain requires long-term use of analgesics
8. Severe liver dysfunction
9. Severe renal dysfunction
10. Severe renal dysfunction
11. Need to receive deep sedation or use neuromuscular blocking drugs
12. Surgery or tracheotomy may be required during the study administration period
13. Used monoamine oxidase inhibitors within the two weeks randomization
14. History of drug abuse, drug use, alcohol abuse, and long-term use of psychotropic drugs within 2 years prior to the start of the screening period
15. QTc abnormality during screening period
16. Positive result for infectious disease
17. Positive screening for drug abuse
18. Pregnant or nursing women;
19. Subjects who has Participated in any other clinical trials within the first 3 months of randomization
20. Other conditions deemed unsuitable to be included.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: Tegileridine Fumarate lnjection	Drug: Tegileridine Fumarate lnjection; Tegileridine Fumarate lnjection; low dose; Drug: Tegileridine Fumarate lnjection; Tegileridine Fumarate lnjection; high dose
Experimental: Treatment group B: Tegileridine Fumarate lnjection	Drug: Tegileridine Fumarate lnjection; Tegileridine Fumarate lnjection; low dose; Drug: Tegileridine Fumarate lnjection; Tegileridine Fumarate lnjection; high dose
Active Comparator: Treatment group C: Remifentanil Hydrochloride for Injection	Drug: Remifentanil Hydrochloride for Injection; Remifentanil Hydrochloride for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of abirritation success, abirritation success is defined as the percentage of time maintaining target abirritation in the entire drug administering time ≥ 70%.	within 3 days after administration of research drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of time maintaining target abirritation in the entire drug administering time.		within 3 days after administration of research drug
Percentage of subjects receiving rescue analgesic drug		within 3 days after administration of research drug
The total dosage of rescue analgesic drug		within 3 days after administration of research drug
Receiving the total dosage of sedation		within 3 days after administration of research drug
Nursing Scores	The investigator will conduct an overall nursing assessment of the subject during the safety follow-up period, and the sum of each score will be calculated : (1) Overall Assessment of Adaptability to Sedation and the Intensive Care Environment, Very Easy=1, Easy =2, Fair =3, Difficult=4; (2) Overall Assessment of Adaptability to Endotracheal Intubation/Ventilation, Good=1, Fair =2,Poor=3; (3) Overall Assessment of Ease of Communication with the Patient, Very Easy=1, Easy =2, Fair =3, Difficult=4, Impossible=5; (4) Overall Assessment of Ease of Patient Care, Good=1, Fair =2,Poor=3.	within 3 days after discontinuation of research drug
Mechanical ventilation time.		From research drug administration to actual extubation , up to 72 hours
Extubation time		From discontinuation of research drug to actual extubation , up to 72 hours

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): February 24, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 20, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Administration Routes; Drug Therapy; Acids, Acyclic; Carboxylic Acids; Piperidines; Propionates; Remifentanil; Injections
• Other Study ID Numbers: SHR8554-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No