NCT06081712

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

A Phase 1, Single-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Multiple Oral Doses of TNP-2198 Capsules in Asymptomatic Subjects With Helicobacter Pylori Infection

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: TenNor Therapeutics (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2020-10-20
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study