NCT06190340

A Phase 1 Study to Evaluate PK Profile of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects

A Phase 1, Single-center, Double-blind, Placebo-controlled Study to Evaluate Pharmacokinetics (PK) and Preliminary Efficacy of Multiple Oral Administrations of TNP-2092 Capsules in Healthy Subjects With Helicobacter Pylori Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: TenNor Therapeutics (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of TNP-2092 Capsules in eradicating Helicobacter pylori.

Detailed description

This study was a single-center, randomized, double-blind, placebo-controlled, dose-ascending multiple-dose-administration study. The aim of this study was to evaluate the safety, tolerability, and pharmacokinetic profile of TNP-2092 Capsules in asymptomatic healthy subjects with Helicobacter pylori infection, and to explore the preliminary efficacy of TNP-2092 Capsules in eradicating Helicobacter pylori. In this study, three dose groups of 100 mg, 300 mg and 600 mg will be set up. The drug will be taken twice a day for 14 consecutive days, and last dose on the morning of Day 15. Fifteen subjects in each of the 100 mg and 300 mg dose groups will be randomized at a ratio of 4:1, with 12 subjects receiving the investigational product and 3 receiving placebo. Ten subjects in the 600 mg dose group will be randomized at a ratio of 4:1, with 8 subjects receiving the investigational product and 2 subjects receiving placebo.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	TNP-2092 capsules	Administration orally.
DRUG	Placebo	Administration orally.

Timeline

• Start date: 2016-11-08
• Primary completion: 2017-09-26
• Completion: 2017-09-26
• First posted: 2024-01-05
• Last updated: 2025-02-27
• Results posted: 2025-01-29

Locations

1 site across 1 country: China