Postoperative Analgesia After Unilateral Hallux Valgus Correction SurgeryPhase 1TRD205NCT07121023
To Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery
A Phase 1 study testing TRD205 tablets in people with Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery
- What is being tested?
- TRD205 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2025to 27 Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
- 5a 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;
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- 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;
- Abnormal liver function in the screening period: ALT and/or AST ≥ 1.5 times the upper limit of normal, or total bilirubin ≥ 1.5 times the upper limit of normal;
- Abnormal renal function in the screening period: serum creatinine (Cr) ≥ 1.5 times of the upper limit of normal and/or dialysis subjects;
- Abnormal coagulation function during screening period: prothrombin time (PT) prolonged by more than 3 seconds and/or activated partial thromboplastin time (APTT) prolonged by more than 10 seconds;
- Syphilis antibody (SyphilisTP) and human immunodeficiency virus antibody (HIV-Ab) test positive at screening Who, in the judgment of the investigator, are not suitable for the trial ;
- Pregnant or lactating women;
- Those who are unwilling or unable to take effective contraceptive measures during the study or 30 times after the study;
- Participated in other drug or device clinical studies (signed ICF and received treatment with investigational drug/device or placebo) within 3 months prior to randomization;
- Other conditions that the investigator considers inappropriate for participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Jishuitan Hosapital
Beijing, Beijing Municipality, 102208
Ning Sun, (010) 5851 6884, jstgcp@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery
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 .
Read the detailed description
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of TRD205 tablets at different doses for postoperative analgesia after unilateral hallux valgus correction surgery.
- Being tested
- TRD205 tablets, Placebo
- Keywords
- TRD205 、Postoperative analgesia、unilateral hallux valgus correction surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRD205 tabletsDrug
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.
TRD205 tabletsDrug
Administered orally every 12 hours for a total of four times；Take TRD205 4 tablets and Placebo 2 tablets for the first time ，TRD205 2 tablets and Placebo 1 tablets each for the other three times.
TRD205 tabletsDrug
Administered orally every 12 hours for a total of four times；Take TRD205 6 tablets and Placebo 0 tablets for the first time ，TRD205 3 tablets and Placebo 0 tablets each for the other three times.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment-Related Adverse Events
Assessment of all AEs, SAEs and TEAEs
Measured: 5 Days
Secondary outcomes (5)
Sum of Pain Intensity Differences from hour 0 to hour 48 (SPID48).Resting state in a resting state
Pain intensity (PI) was assessed using the 11-point numeric pain rating scale (0-10; 0 equated to no pain, and 10 equated to the worst pain imaginable) at predose and at15min、30min、45min、1h、1.5h、2h、2.5h、3h、4h、5h、6h and 8 h, and then at 4-hour intervals until hour 48.
Measured: Within 48 hours after the first administration
Peak Plasma Concentration（Cmax）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Measured: 5 days
Area under the plasma concentration versus time curve （AUC）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Measured: 5 days
time to peak（Tmax）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Measured: 5 days
elimination half life（T1/2）
To evaluate the pharmacokinetic characteristics of multiple administration of TRD205 tablets for postoperative analgesia after unilateral hallux valgus correction surgery
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start26 Aug 2025 (estimated)
- Primary completion27 Dec 2025 (estimated)
- Study completion27 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia After Unilateral Hallux Valgus Correction SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tide Pharmaceutical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Jishuitan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121023
- Sponsor's protocol ID
- TRD205-I-02
- Acronym
- TRD205
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib Clinical Study to Evaluate the Safety, Efficacy and Kinetic Characteristics of TRD205 Tablets for Postoperative Analgesia After Unilateral Hallux Valgus Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07121023
- Acronym / sponsor ID
- TRD205 / TRD205-I-02
- Keywords
- TRD205 、Postoperative analgesia、unilateral hallux valgus correction surgery
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Beijing Tide Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Jishuitan Hospital
- Study start
- 26 Aug 2025 (estimated)
- Primary completion
- 27 Dec 2025 (estimated)
- Study completion
- 27 Dec 2025 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
This study used a placebo as a control to explore the safety, efficacy and pharmacokinetic characteristics of multiple administration of TRD205 tablets at different doses for postoperative analgesia after unilateral hallux valgus correction surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 200mg treatment group | Experimental | Drug: TRD205 tabletsAdministered 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. |
| 400mg treatment group | Experimental | Drug: TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take800mg tablets for the first time and 400mg each for the other three times. |
| 600mg treatment group | Experimental | Drug: TRD205 tabletsAdministered 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. |
| Placebo | Placebo comparator | Drug: PlaceboAdministered 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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) ;
Key exclusion criteria (23 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRD205 tabletsAdministered 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. | Drug | 200mg treatment group |
| TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take TRD205 4 tablets and Placebo 2 tablets for the first time ，TRD205 2 tablets and Placebo 1 tablets each for the other three times. | Drug | 400mg treatment group |
| TRD205 tabletsAdministered orally every 12 hours for a total of four times；Take TRD205 6 tablets and Placebo 0 tablets for the first time ，TRD205 3 tablets and Placebo 0 tablets each for the other three times. | Drug | 600mg treatment group |
| PlaceboAdministered 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. | Drug | Placebo |
Primary outcome
Treatment-Related Adverse Events
Time frame: 5 Days
Assessment of all AEs, SAEs and TEAEs
5 secondary outcomes
Sum of Pain Intensity Differences from hour 0 to hour 48 (SPID48).Resting state in a resting state
Time frame: Within 48 hours after the first administration
Peak Plasma Concentration（Cmax）
Time frame: 5 days
Area under the plasma concentration versus time curve （AUC）
Time frame: 5 days
time to peak（Tmax）
Time frame: 5 days
elimination half life（T1/2）
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRD205 tablets in people with Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery, run by Beijing Tide Pharmaceutical Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yingying wang (+ 86-10-6788-0648-5064, wangyy6@tidepharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment-Related Adverse Events (time frame: 5 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.