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A Clinical Trial of TQB3454 Tablets in Healthy Adult Subjects

NCT06139367 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-11-18

No results posted yet for this study

Summary

This is a randomized, open, parallel, single center phase I clinical trial to evaluate the impact of food on the pharmacokinetics of TQB3454 tablets in healthy adult subjects. The aim is to evaluate the impact of food on the pharmacokinetics as well as the safety after single dose of TQB3454 tablets taken orally by Chinese healthy adult subjects, with pharmacokinetic indicators as the primary endpoint.

Conditions

  • Biliary Carcinoma

Interventions

DRUG

TQB3454 tablets

TQB3454 is a Isocitrate dehydrogenase 1 (IDH1) mutation inhibitor.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-30
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

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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 NCT06139367 on ClinicalTrials.gov