NCT05750355

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

A Single-dose-oral, Ascending-Dose, Single-Center,Randomized, Double-Blind, Placebo-Parallel-controlled Study for the Evaluation of the Effect of TPN171H Tablets on the QT/QTc Intervals in Adult Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Vigonvita Life Sciences · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed description

This trial was a single-center, randomized, double-blind, placebo parallel controlled trial of TPN171H tablets with single oral administration, dose escalation, in healthy Chinese subjects. This trial plans to set up 4 dose groups, and a total of 32 healthy adult subjects are expected to be enrolled. All subjects will receive a single oral dose under fasting state, and complete 3 days of PK blood sampling, 12-lead ECG examination and other safety checks. The trial was sequential according to the principle of dose escalation, that is, the next dose group was tested on the premise that the safety and tolerability of the previous group were good.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-10-10
• Primary completion: 2022-12-07
• Completion: 2022-12-07
• First posted: 2023-03-01
• Last updated: 2023-04-05

Locations

1 site across 1 country: China