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drugset / Trial / NCT07394452

Single Ascending Dose Study(SAD),Multiple Ascending Dose Study(MAD) , High-fat Diet Study (FE) of TJ0113 Capsules in Healthy Subjects

NCT07394452 ↗

Phase 1 Completed 130 enrolled Hangzhou PhecdaMed Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study included three clinical studies, namely a single ascending dose (SAD) study, a multiple ascending dose (MAD) study, and a high-fat diet food effect (FE) study.

Timeline

Start
2023-08-04
Primary completion
2024-02-05
Completion
2024-04-03

Drugs

EvaluationDrugModalityDoseRoute
Subject TJ0113 Unknown 80 mg Oral
Subject TJ0113 Unknown 160 mg Oral
Subject TJ0113 Unknown 200 mg Oral
Subject TJ0113 Unknown 260 mg Oral
Subject TJ0113 Unknown 300 mg Oral
Subject TJ0113 Unknown 400 mg Oral
Subject TJ0113 Unknown 540 mg Oral
Subject TJ0113 Unknown 720 mg Oral

Indications

No indication recorded.