NCT07121023

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Beijing Tide Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 .

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.

Conditions

• Postoperative Analgesia After Unilateral Hallux Valgus Correction Surgery

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-08-26
• Primary completion: 2025-12-27
• Completion: 2025-12-27
• First posted: 2025-08-13
• Last updated: 2025-08-13

Locations

1 site across 1 country: China