To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery

NCT07121023 | Not Yet Recruiting Phase 1

• 1 other identifier: TRD205-I-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery

Keywords

TRD205 、Postoperative analgesia、unilateral hallux valgus correction surgery

Outcome Measures

Primary Outcomes (1)

• Treatment-Related Adverse Events

  Assessment of all AEs, SAEs and TEAEs

  5 Days

Secondary Outcomes (5)

• Sum of Pain Intensity Differences from hour 0 to hour 48 (SPID48).Resting state in a resting state

  Within 48 hours after the first administration

• Peak Plasma Concentration（Cmax）

  5 days

• Area under the plasma concentration versus time curve （AUC）

  5 days

• time to peak（Tmax）

  5 days

• elimination half life（T1/2）

  5 days

Study Arms (4)

200mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take 400mg tablets for the first time and 200mg each for the other three times.

Drug: TRD205 tablets

400mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take800mg tablets for the first time and 400mg each for the other three times.

Drug: TRD205 tablets

600mg treatment group

EXPERIMENTAL

Administered orally every 12 hours for a total of four times；Take 1200mg tablets for the first time and 600mg each for the other three times.

Drug: TRD205 tablets

Placebo

PLACEBO COMPARATOR

Administered orally every 12 hours for a total of four times；Take 6 tablets for the first time and 3 tablets each for the other three times

Drug: Placebo

Interventions

TRD205 tablets DRUG

Administered orally every 12 hours for a total of four times；Take TRD205 2 tablets and Placebo 4 tablets for the first time ，TRD205 1 tablets and Placebo 2 tablets each for the other three times.

200mg treatment group

Placebo DRUG

Administered orally every 12 hours for a total of four times；Take Placebo 6 tablets for the first time ，Placebo 3 tablets each for the other three times.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• to 75 years of age, male or female;
• 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.

You may not qualify if:

• 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 specific types;
• Random First 7 days Inner Use of Chinese herbal medicine with clear analgesic effect as assessed by the investigator;
• Patients who cannot take oral drugs after surgery as judged by the investigator ;
• Combining the following:
• a Subjects with a history of ipsilateral hallux valgus orthopedic surgery; 5b Complicated with other diseases, deformities and traumas of the foot, and unsuitable for participating in this trial as judged by the investigator; 5c Before signing the ICF 3 History of orthopedic surgery for contralateral hallux valgus within a month, and / Or planning to undergo other surgical procedures (e.g., hallux valgus orthopedic surgery, first metatarsophalangeal arthrodesis) at the same time during the trial;
• Concomitant with other pain conditions that may confound the postoperative pain evaluation as judged by the investigator;
• Sitting systolic blood pressure ≤ 90 mmHg , and or sitting diastolic blood pressure ≤ 5 at screening 0 mmHg (does not include abnormalities between admission to the operating room and emergence from anesthesia) The investigator judged that the abnormality was clinically significant;
• Heart rate \< 50 beats per minute or heart rate \> 100 beats per minute (excluding Admission to the operating room until emergence from anesthesia Period abnormality), and the abnormality is clinically significant as judged by the investigator; or QTcF \> 450 ms in males and QTcF \> 470 ms in females \[calculated by Fridericia's formula: QTcF = QT/(RR0.33)\]; or subjects with a history of severe arrhythmia such as type II atrioventricular block or above, or a history of cardiac insufficiency;
• Patients complicated with severe liver, kidney, cardiovascular and cerebrovascular diseases, metabolic system diseases, and should not participate in this trial at the discretion of the investigator;
• Patients with malignant tumor who are not suitable for participating in the study as judged by the investigator ;
• Patients complicated with mental system diseases (such as schizophrenia, depression, etc.), dementia, migraine, history of epilepsy, and unsuitable for participating in the trial judged by the investigator;
• The subject has a history of psychotropic drug and narcotic drug abuse, drug abuse and alcoholism within 1 year prior to randomization, which means he/she drinks on average more than 2 units of alcohol per day (1 unit = 360 mL of beer or 45 mL of 40% liquor or 150 mL of wine);
• Laboratory Abnormalities:
• Abnormal blood routine at screening: neutrophil count \< 1.5 × 10 9 /L; platelet count \< 100 × 10 9 /L; hemoglobin (Hb) \< 80 g/L;

Sponsors & Collaborators

• Beijing Tide Pharmaceutical Co., Ltd: lead
• Beijing Jishuitan Hospital: collaborator

Study Sites (1)

Beijing Jishuitan Hosapital

Beijing, Beijing Municipality, 102208, China

Location

Central Study Contacts

yingying wang

CONTACT

+ 86-10-6788-0648-5064; wangyy6@tidepharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 13, 2025
• Study Start: August 26, 2025
• Primary Completion: December 27, 2025
• Study Completion: December 27, 2025
• Last Updated: August 13, 2025

Record last verified: 2025-08

Locations

CN (1)