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

NCT06190340 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-27

Study results available
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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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

TNP-2092 capsules

Administration orally.

DRUG

Placebo

Administration orally.

Sponsors & Collaborators

  • The First Hospital of Jilin University

    collaborator OTHER

  • TenNor Therapeutics (Suzhou) Limited

    lead INDUSTRY

Principal Investigators

  • Yanhua Ding, MD · The First Hospital of Jilin University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2016-11-08
Primary Completion
2017-09-26
Completion
2017-09-26

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06190340 on ClinicalTrials.gov