At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 40 enrolled
Drug / intervention
TNP-2092 capsules +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating TNP-2092 capsules and Placebo for Helicobacter Pylori Infection. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHelicobacter Pylori Infection
CountriesChina
CollaboratorsThe First Hospital of Jilin University
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartNov 2016
Primary CompletionSep 2017
First PostedJan 2024
TodayJul 2026
First PostedJan 5, 2024
Enrollment StartNov 8, 2016
Primary CompletionSep 26, 2017
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.5 years ago
Interventions
TNP-2092 capsulesdrug
Administration orally.
Placebodrug
Administration orally.