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A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection

NCT06081712 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2023-10-13

No results posted yet for this study

Summary

This study was a Phase 1, single-center, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and preliminary Helicobacter Pylori eradication efficacy of TNP-2198 capsules.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

TNP-2198

TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

DRUG

TNP-2198 Placebo

TNP-2198 capsules/placebo were administered orally twice daily (BID, at 7:00 ± 1 hour in the morning and 19:00 ± 1 hour in the evening) in the fasted state for consecutive 14 days, and the last dose was taken at 7:00 am (±1 hour) on Day 15 in the fasted state, and breakfast or dinner should not be taken within 30 minutes after each dose.

Sponsors & Collaborators

  • TenNor Therapeutics (Suzhou) Limited

    lead INDUSTRY

Principal Investigators

  • TenNor Clinical Trials · TenNor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2021-07-15
Completion
2021-07-15
FDA Drug
Yes

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 NCT06081712 on ClinicalTrials.gov