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Evaluate the Effect of TPN171H on the QT/QTc Interval in Healthy Volunteers

NCT05750355 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-04-05

No results posted yet for this study

Summary

This is a single-dose orally administered, dose-escalation, single-center, randomized, double-blind, placebo-parallel controlled clinical study evaluating the effect of TPN171H tablets on QT/QTc interval in healthy subjects.The main objective was to evaluate the effect of TPN171H tablets on QT/QTc interval in healthy Chinese subjects after a single oral administration.

Conditions

  • Healthy Subjects

Interventions

DRUG

TPN171H 10 mg Group

6 subjects will receive TPN171H 10 mg, orally; 2 subjects will receive placebo, orally.

DRUG

TPN171H 30 mg Group

6 subjects will receive TPN171H 30 mg, orally; 2 subjects will receive placebo, orally.

DRUG

TPN171H 40 mg Group

6 subjects will receive TPN171H 40 mg, orally; 2 subjects will receive placebo, orally.

DRUG

TPN171H 50 mg Group

6 subjects will receive TPN171H 50 mg, orally; 2 subjects will receive placebo, orally.

Sponsors & Collaborators

  • Vigonvita Life Sciences

    lead INDUSTRY

Principal Investigators

  • Jing Zhang · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2022-12-07
Completion
2022-12-07

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 NCT05750355 on ClinicalTrials.gov