To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative … (NCT07121023) | Clinical Trial Compass
Not Yet RecruitingPhase 1
To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery
China32 participantsStarted 2025-08-26
Plain-language summary
This is a multicenter, randomized, double-blind, placebo-controlled phase Ib study designed to evaluate the safety, efficacy and PK of TRD205 tablets administered orally .
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Fully understand the purpose and significance of this study, voluntarily participate in this study, voluntarily sign the informed consent form, and voluntarily comply with the trial procedures;
* 18 to 75 years of age, male or female;
* 18 kg/m 2 ≤ BMI ≤ 30 kg/m 2 , Include Cut-off value ;
* American Society of Anesthesiologists (ASA) physical status I to II (Appendix) 6 );
* Elective unilateral hallux valgus orthopedic surgery under general anesthesia (distal osteotomy of the first metatarsal, which can be combined with phalangeal osteotomy) , post-op NRS ≥ 4 points at rest within 4h (timed from the completion of the last suture) ;
* Able to understand the study procedures and the use of various scales involved in this study, and able to communicate effectively with the investigators.
Exclusion Criteria:
* Known allergies or contraindications to the investigational drug and other drugs that may be used during the trial, and those who are not suitable for participating in the trial judged by the investigator;
* Before randomization 5 half-lives The following drugs (subject to the actual package insert, with half-life unknown, then washout at 48h) are used internally, including but not limited to: analgesic drugs (except those specified in the protocol), anticonvulsants, sedative and hypnotic drugs (except those specified in the protocol), anxiolytics, antidepressants, CYP3A4 enzyme inhibitors or inducers, etc. See the List of Prohibited Drugs for the …