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

NCT07121023 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-13

No results posted yet for this study

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

Interventions

DRUG

TRD205 tablets

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.

DRUG

TRD205 tablets

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.

DRUG

TRD205 tablets

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.

DRUG

Placebo

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.

Sponsors & Collaborators

  • Beijing Jishuitan Hospital

    collaborator OTHER

  • Beijing Tide Pharmaceutical Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-26
Primary Completion
2025-12-27
Completion
2025-12-27

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121023 on ClinicalTrials.gov