NCT06081699

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of TNP-2198 Capsules in Healthy Participants and the Effect of Food on the Pharmacokinetics of TNP-2198 Capsules in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: TenNor Therapeutics (Suzhou) Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a single-center, randomized, double-blind, placebo-controlled phase 1 study to evaluate the safety, tolerability, pharmacokinetics of single ascending dose and the food effect on the pharmacokinetics of TNP-2198 capsules after single dose oral administration in healthy subjects.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	TNP-2198	Oral
DRUG	TNP-2198 Placebo	The placebo for TNP-2198 active drug

Timeline

• Start date: 2019-05-09
• Primary completion: 2019-09-18
• Completion: 2019-09-18
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study